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出境医 / 临床实验 / Intraoperative Goal-directed Blood Pressure and Dexmedetomidine

Intraoperative Goal-directed Blood Pressure and Dexmedetomidine

Study Description
Brief Summary:
Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.

Condition or disease Intervention/treatment Phase
Blood Pressure Dexmedetomidine High-risk Patients Abdominal Surgery Postoperative Complications Drug: Dexmedetomidine Drug: Placebo Other: Goal-directed blood pressure management Other: Routine blood pressure management Phase 4

Detailed Description:

The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes.

Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy.

Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive.

This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a 2x2 factorial trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: For dexmedetomidine infusion, all the participants, care providers, investigators, outcomes assessors are masked. For blood pressure management, care providers, namely anesthesiologists, are not masked.
Primary Purpose: Prevention
Official Title: Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : October 29, 2020
Estimated Study Completion Date : May 2023
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
 Drug: Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Other Name: Normal saline

Other: Routine blood pressure management
Blood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.
Experimental: Dexmedetomidine+routine blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
 Drug: Dexmedetomidine
Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
Other Name: Dexmedetomidine hydrochloride injection

Other: Routine blood pressure management
Blood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.
Experimental: Placebo+goal-directed blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
 Drug: Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Other Name: Normal saline

Other: Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Experimental: Dexmedetomidine+goal-directed blood pressure management
Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
 Drug: Dexmedetomidine
Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
Other Name: Dexmedetomidine hydrochloride injection

Other: Goal-directed blood pressure management
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of organ injury and other complications within 30 days after surgery. [ Time Frame: Up to 30 days after surgery. ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.


Secondary Outcome Measures :
  1. Incidence of organ injury and other complications within 7 days after surgery. [ Time Frame: Up to 7 days after surgery. ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.

  2. Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in the intensive care unit after surgery.

  3. Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.

  4. 30-day all-cause mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of death due to any cause within 30 days after surgery.

  5. Overall survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Overall survival within 2 years after surgery.

  6. Disease-free survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Disease-free survival within 2 years after surgery.

  7. Quality of life of 2-year survivors: WHOQOL-BREF [ Time Frame: At the end of 2 years after surgery. ]
    Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).

  8. Cognition function of 2-year survivors. [ Time Frame: At the end of 2 years after surgery. ]
    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50 years or older;
  • Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
  • With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).

Exclusion Criteria:

  • Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
  • Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
  • Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
  • Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
  • Pregnant;
  • Receiving dexmedetomidine or norepinephrine infusion before surgery;
  • Do not provide written informed consent.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Tracking Information
First Submitted Date  ICMJE April 27, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE May 20, 2019
Actual Primary Completion Date October 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Incidence of organ injury and other complications within 30 days after surgery. [ Time Frame: Up to 30 days after surgery. ]
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Incidence of organ injury and other complications within 7 days after surgery. [ Time Frame: Up to 7 days after surgery. ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
  • Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in the intensive care unit after surgery.
  • Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.
  • 30-day all-cause mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of death due to any cause within 30 days after surgery.
  • Overall survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Overall survival within 2 years after surgery.
  • Disease-free survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Disease-free survival within 2 years after surgery.
  • Quality of life of 2-year survivors: WHOQOL-BREF [ Time Frame: At the end of 2 years after surgery. ]
    Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
  • Cognition function of 2-year survivors. [ Time Frame: At the end of 2 years after surgery. ]
    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Incidence of organ injury and other complications within 7 days after surgery. [ Time Frame: Up to 7 days after surgery. ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
  • Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in the intensive care unit after surgery.
  • Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.
  • 30-day all-cause mortality. [ Time Frame: Up to 30 days after surgery. ]
    30-day all-cause mortality.
  • Overall survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Overall survival within 2 years after surgery.
  • Disease-free survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Disease-free survival within 2 years after surgery.
  • Quality of life of 2-year survivors: WHOQOL-BREF [ Time Frame: At the end of 2 years after surgery. ]
    Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
  • Cognition function of 2-year survivors. [ Time Frame: At the end of 2 years after surgery. ]
    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Goal-directed Blood Pressure and Dexmedetomidine
Official Title  ICMJE Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial
Brief Summary Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.
Detailed Description

The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes.

Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy.

Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive.

This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
This is a 2x2 factorial trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
For dexmedetomidine infusion, all the participants, care providers, investigators, outcomes assessors are masked. For blood pressure management, care providers, namely anesthesiologists, are not masked.
Primary Purpose: Prevention
Condition  ICMJE
  • Blood Pressure
  • Dexmedetomidine
  • High-risk Patients
  • Abdominal Surgery
  • Postoperative Complications
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
    Other Name: Dexmedetomidine hydrochloride injection
  • Drug: Placebo
    Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
    Other Name: Normal saline
  • Other: Goal-directed blood pressure management
    Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
  • Other: Routine blood pressure management
    Blood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.
Study Arms  ICMJE
  • Placebo Comparator: Placebo+routine blood pressure management
    Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
    Interventions:
    • Drug: Placebo
    • Other: Routine blood pressure management
  • Experimental: Dexmedetomidine+routine blood pressure management
    Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
    Interventions:
    • Drug: Dexmedetomidine
    • Other: Routine blood pressure management
  • Experimental: Placebo+goal-directed blood pressure management
    Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
    Interventions:
    • Drug: Placebo
    • Other: Goal-directed blood pressure management
  • Experimental: Dexmedetomidine+goal-directed blood pressure management
    Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
    Interventions:
    • Drug: Dexmedetomidine
    • Other: Goal-directed blood pressure management
Publications *
  • Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
  • Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. Erratum in: Anesthesiology. 2016 Mar;124(3):741-2.
  • Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vásquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
  • Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
  • Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
  • Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
  • Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
  • Memiş D, Hekimoğlu S, Vatan I, Yandim T, Yüksel M, Süt N. Effects of midazolam and dexmedetomidine on inflammatory responses and gastric intramucosal pH to sepsis, in critically ill patients. Br J Anaesth. 2007 Apr;98(4):550-2.
  • Xiang H, Hu B, Li Z, Li J. Dexmedetomidine controls systemic cytokine levels through the cholinergic anti-inflammatory pathway. Inflammation. 2014 Oct;37(5):1763-70. doi: 10.1007/s10753-014-9906-1.
  • Cho JS, Kim HI, Lee KY, An JY, Bai SJ, Cho JY, Yoo YC. Effect of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movements in Patients Undergoing Laparoscopic Gastrectomy: A Prospective, Randomized, Placebo-Controlled Study. Medicine (Baltimore). 2015 Jun;94(24):e959. doi: 10.1097/MD.0000000000000959.
  • Kocoglu H, Karaaslan K, Gonca E, Bozdogan O, Gulcu N. Preconditionin effects of dexmedetomidine on myocardial ischemia/reperfusion injury in rats. Curr Ther Res Clin Exp. 2008 Apr;69(2):150-8. doi: 10.1016/j.curtheres.2008.04.003.
  • Cheng J, Zhu P, Qin H, Li X, Yu H, Yu H, Peng X. Dexmedetomidine attenuates cerebral ischemia/reperfusion injury in neonatal rats by inhibiting TLR4 signaling. J Int Med Res. 2018 Jul;46(7):2925-2932. doi: 10.1177/0300060518781382. Epub 2018 Jun 21.
  • Sahin T, Begeç Z, Toprak Hİ, Polat A, Vardi N, Yücel A, Durmuş M, Ersoy MÖ. The effects of dexmedetomidine on liver ischemia-reperfusion injury in rats. J Surg Res. 2013 Jul;183(1):385-90. doi: 10.1016/j.jss.2012.11.034. Epub 2012 Dec 8.
  • Hanci V, Yurdakan G, Yurtlu S, Turan IÖ, Sipahi EY. Protective effect of dexmedetomidine in a rat model of α-naphthylthiourea-induced acute lung injury. J Surg Res. 2012 Nov;178(1):424-30. doi: 10.1016/j.jss.2012.02.027. Epub 2012 Mar 9.
  • Kocoglu H, Ozturk H, Ozturk H, Yilmaz F, Gulcu N. Effect of dexmedetomidine on ischemia-reperfusion injury in rat kidney: a histopathologic study. Ren Fail. 2009;31(1):70-4. doi: 10.1080/08860220802546487.
  • Duncan D, Sankar A, Beattie WS, Wijeysundera DN. Alpha-2 adrenergic agonists for the prevention of cardiac complications among adults undergoing surgery. Cochrane Database Syst Rev. 2018 Mar 6;3:CD004126. doi: 10.1002/14651858.CD004126.pub3. Review.
  • Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.
  • Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da. Review.
  • Khwannimit B, Bhurayanontachai R. Prediction of fluid responsiveness in septic shock patients: comparing stroke volume variation by FloTrac/Vigileo and automated pulse pressure variation. Eur J Anaesthesiol. 2012 Feb;29(2):64-9. doi: 10.1097/EJA.0b013e32834b7d82.
  • Trepte CJ, Eichhorn V, Haas SA, Stahl K, Schmid F, Nitzschke R, Goetz AE, Reuter DA. Comparison of an automated respiratory systolic variation test with dynamic preload indicators to predict fluid responsiveness after major surgery. Br J Anaesth. 2013 Nov;111(5):736-42. doi: 10.1093/bja/aet204. Epub 2013 Jun 27.
  • Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.
  • Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454. Review.
  • Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X.
  • Fourth universal definition of myocardial infarction (2018). Rev Esp Cardiol (Engl Ed). 2019 Jan;72(1):72. doi: 10.1016/j.rec.2018.11.011. English, Spanish.
  • Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
  • Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. Review.
  • Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009 Jun;40(6):2276-93. doi: 10.1161/STROKEAHA.108.192218. Epub 2009 May 7. Review.
  • Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9.
  • Konstantinides SV. 2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Dec 1;35(45):3145-6. doi: 10.1093/eurheartj/ehu393.
  • Scarvelis D, Wells PS. Diagnosis and treatment of deep-vein thrombosis. CMAJ. 2006 Oct 24;175(9):1087-92. Review. Erratum in: CMAJ. 2007 Nov 20;177(11):1392.
  • Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. Erratum in: Am J Infect Control. 2008 Nov;36(9):655.
  • Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288. Erratum in: JAMA. 2016 May 24-31;315(20):2237.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2019) 		496
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Actual Primary Completion Date October 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 50 years or older;
  • Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
  • With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).

Exclusion Criteria:

  • Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
  • Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
  • Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
  • Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
  • Pregnant;
  • Receiving dexmedetomidine or norepinephrine infusion before surgery;
  • Do not provide written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933306
Other Study ID Numbers  ICMJE 2019-73
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dong-Xin Wang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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