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出境医 / 临床实验 / Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery

Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery

Study Description
Brief Summary:
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.

Condition or disease Intervention/treatment Phase
Hepatic Complication Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). Phase 1 Phase 2

Detailed Description:

Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting , bowel preparation, and intra- and postoperative fluid and electrolyte loss(1). So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years. The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussions and ongoing controversy on colloids versus crystalloids(2-5) and the ideal composition of the various intravenous solutions(6-8),the main focus more recently has been on the volume of fluids.

Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time. (9-11).

However , a restrictive fluid regimen has several limitations (12). Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction(13), prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.(14, 15) Recently, The Pleth variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained noninvasively. (16-18) PVI is calculated as [(PImax - PImin)/PImax] X 100, where PImax and PImin represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle (16, 19). PI is the ratio between pulsatile and no pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform (20). A PVI value of >13% before volume expansion discriminated between fluid responders and non-responders with 81% sensitivity and 100% specificity.

An extremely important feature of fluid therapy is ability to modulate inflammatory response in all its aspects with impact on a rate of neutrophil activation and modulation of cytokine and adhesive molecules expression. Isotonic sodium chloride solution and Ringer's lactate solution were shown to have pro-inflammatory properties while so called low volume therapy. Saline solution seems to be the most pro-inflammatory infusion fluid exerting negative impact on both macro- and microcirculation (21). Infusions of high volume of sodium chloride result in elevated serum chloride levels leading to acid-base imbalance and increase of free hydrogen ions (22).

Some available literature data show potential impact of Ringer's lactate therapy on induction of inflammatory response (23) but other reports do not support such phenomenon (24). Acetates similarly to lactates act as buffers and are easily broken down to bicarbonates. The difference between them is that lactates are metabolized mainly in the liver while acetates are metabolized in all body cells. The latter is especially beneficial in liver insufficiency, lactic acidosis and microcirculation insufficiency leading to organ hypoperfusion.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Group (R)
Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery

Experimental: Group (C)
Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).
Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery

Outcome Measures
Primary Outcome Measures :
  1. SGPT change pre- and postoperative [ Time Frame: preoperative and in the first and second day postoperative ]
    effects of different fluid strategies in change of SGBT level pre- and postoperative


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients>18 years old, undergoing elective hepatobiliary surgery under general anesthesia and American Society of Anesthesiologists grade II.

Exclusion Criteria:

  • 1-patient refusal. 2-psychiatric disorders. 3-pregnancy and lactation. 4-preexisting neurological dysfunction (history of cerebrovascular stroke CVS) 5-metastatic cancer. 6-Inflammatory bowel disease. 7-Diabetes mellitus. 8-Renal insufficiency (serum creatinine level more than 180 μmol/l). 9- unexpected intraoperative findings (inoperable). 10-accidental massive intraoperative hemorrhage.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ahmed Safwat +201011237474 a.safwat1988@gmail.com
Contact: Emad Zarief +201007046058 emadzarief@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Emad Zarief, assistant professor Assiut University
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 23, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
SGPT change pre- and postoperative [ Time Frame: preoperative and in the first and second day postoperative ]
effects of different fluid strategies in change of SGBT level pre- and postoperative
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery
Official Title  ICMJE Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
Brief Summary compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.
Detailed Description

Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting , bowel preparation, and intra- and postoperative fluid and electrolyte loss(1). So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years. The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussions and ongoing controversy on colloids versus crystalloids(2-5) and the ideal composition of the various intravenous solutions(6-8),the main focus more recently has been on the volume of fluids.

Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time. (9-11).

However , a restrictive fluid regimen has several limitations (12). Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction(13), prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.(14, 15) Recently, The Pleth variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained noninvasively. (16-18) PVI is calculated as [(PImax - PImin)/PImax] X 100, where PImax and PImin represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle (16, 19). PI is the ratio between pulsatile and no pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform (20). A PVI value of >13% before volume expansion discriminated between fluid responders and non-responders with 81% sensitivity and 100% specificity.

An extremely important feature of fluid therapy is ability to modulate inflammatory response in all its aspects with impact on a rate of neutrophil activation and modulation of cytokine and adhesive molecules expression. Isotonic sodium chloride solution and Ringer's lactate solution were shown to have pro-inflammatory properties while so called low volume therapy. Saline solution seems to be the most pro-inflammatory infusion fluid exerting negative impact on both macro- and microcirculation (21). Infusions of high volume of sodium chloride result in elevated serum chloride levels leading to acid-base imbalance and increase of free hydrogen ions (22).

Some available literature data show potential impact of Ringer's lactate therapy on induction of inflammatory response (23) but other reports do not support such phenomenon (24). Acetates similarly to lactates act as buffers and are easily broken down to bicarbonates. The difference between them is that lactates are metabolized mainly in the liver while acetates are metabolized in all body cells. The latter is especially beneficial in liver insufficiency, lactic acidosis and microcirculation insufficiency leading to organ hypoperfusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Hepatic Complication
Intervention  ICMJE Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery
Study Arms  ICMJE
  • Experimental: Group (R)
    Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
    Intervention: Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
  • Experimental: Group (C)
    Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).
    Intervention: Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients>18 years old, undergoing elective hepatobiliary surgery under general anesthesia and American Society of Anesthesiologists grade II.

Exclusion Criteria:

  • 1-patient refusal. 2-psychiatric disorders. 3-pregnancy and lactation. 4-preexisting neurological dysfunction (history of cerebrovascular stroke CVS) 5-metastatic cancer. 6-Inflammatory bowel disease. 7-Diabetes mellitus. 8-Renal insufficiency (serum creatinine level more than 180 μmol/l). 9- unexpected intraoperative findings (inoperable). 10-accidental massive intraoperative hemorrhage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed Safwat +201011237474 a.safwat1988@gmail.com
Contact: Emad Zarief +201007046058 emadzarief@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923816
Other Study ID Numbers  ICMJE fluids and hepatic outcome
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Ahmed Safwat, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emad Zarief, assistant professor Assiut University
PRS Account Assiut University
Verification Date April 2019

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