Blood Pressure Clinical Trial
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
Verified date | March 2024 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 496 |
Est. completion date | May 2024 |
Est. primary completion date | October 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 30 days after surgery. | |
Secondary | 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. | Up to 7 days after surgery. | |
Secondary | Length of stay in the intensive care unit after surgery. | Length of stay in the intensive care unit after surgery. | Up to 30 days after surgery. | |
Secondary | Length of stay in hospital after surgery. | Length of stay in hospital after surgery. | Up to 30 days after surgery. | |
Secondary | 30-day all-cause mortality. | Rate of death due to any cause within 30 days after surgery. | Up to 30 days after surgery. | |
Secondary | Overall survival after surgery. | Overall survival after surgery. | Up to 3 years after surgery. | |
Secondary | Disease-free survival after surgery. | Disease-free survival after surgery. | Up to 3 years after surgery. | |
Secondary | 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). | At the end of 2 years after surgery. | |
Secondary | Cognition function of 2-year survivors. | Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m). | At the end of 2 years after surgery. |
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