Back to resultsIntraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
Primary Purpose
Blood Pressure, Dexmedetomidine, High-risk Patients
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Goal-directed blood pressure management
Routine blood pressure management
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure focused on measuring blood pressure management, dexmedetomidine, high-risk patients, abdominal surgery, postoperative organ injury
Eligibility 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.
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo+routine blood pressure management
Dexmedetomidine+routine blood pressure management
Placebo+goal-directed blood pressure management
Dexmedetomidine+goal-directed blood pressure management
Arm Description
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
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.
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid 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.
Outcomes
Primary Outcome Measures
Incidence of organ injury and other complications within 30 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Secondary Outcome Measures
Incidence of organ injury and other complications within 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.
Length of stay in the intensive care unit after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
30-day all-cause mortality.
Rate of death due to any cause within 30 days after surgery.
Overall survival within 2 years after surgery.
Overall survival within 2 years after surgery.
Disease-free survival within 2 years after surgery.
Disease-free survival within 2 years after surgery.
Quality of life of 2-year survivors: WHOQOL-BREF
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.
Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Full Information
NCT ID
NCT03933306
First Posted
April 27, 2019
Last Updated
April 19, 2022
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03933306
Brief Title
Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Dexmedetomidine, High-risk Patients, Abdominal Surgery, Postoperative Complications
Keywords
blood pressure management, dexmedetomidine, high-risk patients, abdominal surgery, postoperative organ injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
This is a 2x2 factorial trial
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
496 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo+routine blood pressure management
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Arm Title
Dexmedetomidine+routine blood pressure management
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo+goal-directed blood pressure management
Arm Type
Experimental
Arm Description
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Arm Title
Dexmedetomidine+goal-directed blood pressure management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine hydrochloride injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Intervention Type
Other
Intervention Name(s)
Goal-directed blood pressure management
Intervention Description
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Intervention Type
Other
Intervention Name(s)
Routine blood pressure management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of organ injury and other complications within 30 days after surgery.
Description
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Time Frame
Up to 30 days after surgery.
Secondary Outcome Measure Information:
Title
Incidence of organ injury and other complications within 7 days after surgery.
Description
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Time Frame
Up to 7 days after surgery.
Title
Length of stay in the intensive care unit after surgery.
Description
Length of stay in the intensive care unit after surgery.
Time Frame
Up to 30 days after surgery.
Title
Length of stay in hospital after surgery.
Description
Length of stay in hospital after surgery.
Time Frame
Up to 30 days after surgery.
Title
30-day all-cause mortality.
Description
Rate of death due to any cause within 30 days after surgery.
Time Frame
Up to 30 days after surgery.
Title
Overall survival within 2 years after surgery.
Description
Overall survival within 2 years after surgery.
Time Frame
Up to 2 years after surgery.
Title
Disease-free survival within 2 years after surgery.
Description
Disease-free survival within 2 years after surgery.
Time Frame
Up to 2 years after surgery.
Title
Quality of life of 2-year survivors: WHOQOL-BREF
Description
Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
Time Frame
At the end of 2 years after surgery.
Title
Cognition function of 2-year survivors.
Description
Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Time Frame
At the end of 2 years after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
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