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出境医 / 临床实验 / Antihypertensives in Non-cardiac Surgical Population

Antihypertensives in Non-cardiac Surgical Population

Study Description
Brief Summary:
A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to investigate current status of antihypertensive drug treatment in non-cardiac surgical population.

Condition or disease
Perioperative Antihypertensive

Detailed Description:
Perioperative changes in blood pressure (BP) are associated with perioperative risks. However, there is little information regarding the current status of antihypertensive treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to investigate the application of antihypertensive drugs, systemic involvement, perioperative hemodynamics and internal environment to grasp the perioperative impact of different antihypertensive drugs, and to further provide a reference for the preoperative antihypertensive strategy of surgery patients.
Study Design
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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Current Status of Antihypertensive Drug Treatment in Non-cardiac Surgical Population
Actual Study Start Date : November 23, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019
Arms and Interventions
Group/Cohort
ARB
Group of angiotensin receptor blockers(ARB) monotherapy users. A subject was considered as an ARB user when the total prescription days of ARB monotherapy was at least 30.
combination of CCB and ARB
Group of calcium channel blockers(CCB) and angiotensin receptor blockers(ARB) combination users. A subject was considered as a CCB and ARB combination user when the total prescription days of CCB and ARB combination therapy was at least 30.
CCB
Group of calcium channel blockers(CCB) monotherapy users. A subject was considered as a CCB user when the total prescription days of CCB monotherapy was at least 30.
No treatment
Group of nonusers of antihypertensives. A subject was considered as a nonuser never received regular antihypertensive treatment or total prescription days of antihypertensives was less than 30.
Outcome Measures
Primary Outcome Measures :
  1. perioperative blood press(BP) [ Time Frame: from the moment on arrival to the operating room until the moment leaving PACU, assessed up to 240 minutes. ]
    baseline BP before the operation, when entering and exiting post-anesthesia care unit(PACU)


Secondary Outcome Measures :
  1. pH, base excess, and concentration of HCO3- in blood gases [ Time Frame: 5 minutes after extubating in PACU ]
    arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)

  2. the incidence of hypotension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    If there were more than two consecutive episodes of hypotension (which was defined as SBP less than 80% of baseline) a "rescue" intravenous bolus of 100 mg of phenylephrine was given.

  3. the incidence of hypertension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    the incidence of hypertension, which was defined as SBP greater than 120% of baseline

  4. hospitalization days [ Time Frame: from the date of admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days ]
    The duration of this single episode of hospitalization


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing elective non-cardiac surgery in Renji hospital
Criteria

Inclusion Criteria:

  • patients undergoing elective non-cardiac surgery with hypertension(i.e., with a systolic blood pressure(SBP) of >=140 mmHg and/or a diastolic blood pressure(DBP) of >=90 mmHg based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) or self-reported use of antihypertensive medication

Exclusion Criteria:

  • Patients under the age of 18 years old
  • Patients more than 85 years old
  • Patients suspected of intracranial hypertension
Contacts and Locations

Locations
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China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Jie Chen, M.S. Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
Tracking Information
First Submitted Date April 27, 2019
First Posted Date May 17, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date November 23, 2018
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019) 		perioperative blood press(BP) [ Time Frame: from the moment on arrival to the operating room until the moment leaving PACU, assessed up to 240 minutes. ]
baseline BP before the operation, when entering and exiting post-anesthesia care unit(PACU)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 16, 2019)
  • pH, base excess, and concentration of HCO3- in blood gases [ Time Frame: 5 minutes after extubating in PACU ]
    arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)
  • the incidence of hypotension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    If there were more than two consecutive episodes of hypotension (which was defined as SBP less than 80% of baseline) a "rescue" intravenous bolus of 100 mg of phenylephrine was given.
  • the incidence of hypertension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    the incidence of hypertension, which was defined as SBP greater than 120% of baseline
  • hospitalization days [ Time Frame: from the date of admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days ]
    The duration of this single episode of hospitalization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antihypertensives in Non-cardiac Surgical Population
Official Title Current Status of Antihypertensive Drug Treatment in Non-cardiac Surgical Population
Brief Summary A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to investigate current status of antihypertensive drug treatment in non-cardiac surgical population.
Detailed Description Perioperative changes in blood pressure (BP) are associated with perioperative risks. However, there is little information regarding the current status of antihypertensive treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to investigate the application of antihypertensive drugs, systemic involvement, perioperative hemodynamics and internal environment to grasp the perioperative impact of different antihypertensive drugs, and to further provide a reference for the preoperative antihypertensive strategy of surgery patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing elective non-cardiac surgery in Renji hospital
Condition Perioperative Antihypertensive
Intervention Not Provided
Study Groups/Cohorts
  • ARB
    Group of angiotensin receptor blockers(ARB) monotherapy users. A subject was considered as an ARB user when the total prescription days of ARB monotherapy was at least 30.
  • combination of CCB and ARB
    Group of calcium channel blockers(CCB) and angiotensin receptor blockers(ARB) combination users. A subject was considered as a CCB and ARB combination user when the total prescription days of CCB and ARB combination therapy was at least 30.
  • CCB
    Group of calcium channel blockers(CCB) monotherapy users. A subject was considered as a CCB user when the total prescription days of CCB monotherapy was at least 30.
  • No treatment
    Group of nonusers of antihypertensives. A subject was considered as a nonuser never received regular antihypertensive treatment or total prescription days of antihypertensives was less than 30.
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 Completed
Actual Enrollment
 (submitted: May 16, 2019) 		351
Original Actual Enrollment Same as current
Actual Study Completion Date April 1, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients undergoing elective non-cardiac surgery with hypertension(i.e., with a systolic blood pressure(SBP) of >=140 mmHg and/or a diastolic blood pressure(DBP) of >=90 mmHg based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) or self-reported use of antihypertensive medication

Exclusion Criteria:

  • Patients under the age of 18 years old
  • Patients more than 85 years old
  • Patients suspected of intracranial hypertension
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953872
Other Study ID Numbers antihypertensives 2019
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 Not Provided
Responsible Party RenJi Hospital
Study Sponsor RenJi Hospital
Collaborators Not Provided
Investigators
Study Chair: Jie Chen, M.S. Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
PRS Account RenJi Hospital
Verification Date May 2019

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