Clinical trial NCT03629418: Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery
Official title: Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass, Off-Pump
Intraoperative Hypotension
Acute Kidney Injury
Preventive Medicine
Intraoperative Care
Keywords: Coronary Artery Bypass, Off-Pump
Intraoperative Hypotension
Acute Kidney Injury
Preventive Medicine
Intraoperative Care
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 612
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.

Detailed description: Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure \[SBP\] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years;
* Scheduled to undergo off-pump CABG surgery.

Exclusion Criteria:

* Refuse to participate;
* Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Chronic kidney disease with a glomerular filtration rate \< 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
* Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
* Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
* Second or emergency surgery;
* Expected survival of less than 24 hours.

Primary outcomes:
measure: Incidence of acute kidney injury (AKI) within 7 days after surgery
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Classification of AKI within 7 days after surgery
timeFrame: Up to 7 days after surgery
measure: Incidence of delirium within 7 days after surgery
timeFrame: Up to 7 days after surgery
measure: Duration of mechanical ventilation after surgery
timeFrame: Up to 30 days after surgery
measure: Length of stay in intensive care unit (ICU) 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: Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of non-MACE complications within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: All-cause 30-day mortality
timeFrame: At 30 days after surgery
measure: 2-year overall survival after surgery
timeFrame: Up to 2 years after surgery
measure: 2-year major adverse cardiovascular event (MACE)-free survival after surgery
timeFrame: Up to 2 years after surgery
measure: Cognitive function in 1- and 2-year survivors
timeFrame: At the end of the 1st and 2nd years after surgery
measure: Quality of life in 1- and 2- year survivors: SF-36
timeFrame: At the end of the 1st and 2nd years after surgery
Other outcomes:
measure: Pain severity within 3 days after surgery: NRS
timeFrame: Up to 3 days after surgery
measure: Daily prevalence of delirium during postoperative days 1-7
timeFrame: During the first 7 days after surgery
measure: Duration of intraoperative cerebral desaturation (sub-study)
timeFrame: During surgery
Locations:
city: Beijing
country: China
facility: Beijing 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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