Clinical trial NCT03933306: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Blood Pressure
Dexmedetomidine
High-risk Patients
Abdominal Surgery
Postoperative Complications
Keywords: blood pressure management
dexmedetomidine
high-risk patients
abdominal surgery
postoperative organ injury
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 496
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2x2 factorial trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of organ injury and other complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
Secondary outcomes:
measure: Incidence of organ injury and other complications within 7 days after surgery.
timeFrame: Up to 7 days after surgery.
measure: Length of stay in the intensive care unit after surgery.
timeFrame: Up to 30 days after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: 30-day all-cause mortality.
timeFrame: Up to 30 days after surgery.
measure: Overall survival after surgery.
timeFrame: Up to 3 years after surgery.
measure: Disease-free survival after surgery.
timeFrame: Up to 3 years after surgery.
measure: Quality of life of 2-year survivors: WHOQOL-BREF
timeFrame: At the end of 2 years after surgery.
measure: Cognition function of 2-year survivors.
timeFrame: At the end of 2 years after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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