Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial

Conditions
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Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care

Intervention / Treatment
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* Drug: Targeted blood-pressure management
* Drug: Routine blood-pressure management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted blood-pressure management<br>Prophylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery. | Drug: Targeted blood-pressure management<br>* Prophylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher.<br>* Other names: Norepinephrine;|
| Active Comparator: Routine blood-pressure management<br>Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery. | Drug: Routine blood-pressure management<br>* Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.<br>* Other names: Phenylephrine and other vasopressors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury (AKI) within 7 days after surgery | Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria | Up to 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of AKI within 7 days after surgery | Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria | Up to 7 days after surgery | 
| Incidence of delirium within 7 days after surgery | Development of delirium within 7 days after surgery is assessed with the Confusion Assessment Method (3D-CAM for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation). | Up to 7 days after surgery | 
| Duration of mechanical ventilation after surgery | Duration of mechanical ventilation after surgery | Up to 30 days after surgery | 
| Length of stay in intensive care unit (ICU) after surgery | Length of stay in intensive care unit (ICU) after surgery | Up to 30 days after surgery | 
| Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | 
| Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery | MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke. | Up to 30 days after surgery | 
| Incidence of non-MACE complications within 30 days after surgery | Non-MACE complications within 30 days after surgery indicate new-onset medical conditions other than MACEs that produce harmful effects on patients' recovery and required therapeutic intervention. | Up to 30 days after surgery | 
| All-cause 30-day mortality | All-cause 30-day mortality | At 30 days after surgery | 
| 2-year overall survival after surgery | 2-year overall survival after surgery | Up to 2 years after surgery | 
| 2-year major adverse cardiovascular event (MACE)-free survival after surgery | MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke. | Up to 2 years after surgery | 
| Cognitive function in 1- and 2-year survivors | Cognitive function in 1- and 2-year survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m, score ranges from 0 to 40, with higher score indicating better function). | At the end of the 1st and 2nd years after surgery | 
| Quality of life in 1- and 2- year survivors: SF-36 | Quality of life in 1- and 2-year survivors is assessed with the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates 8 different domains of quality of life, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The score of each domain ranges from 0 to 100, with high score indicating better function. | At the end of the 1st and 2nd years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care