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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
612
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.
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.
Beijing University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence 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
Time frame: Up to 7 days after surgery
Classification of AKI within 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
Time frame: 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).
Time frame: Up to 7 days after surgery
Duration of mechanical ventilation after surgery
Duration of mechanical ventilation after surgery
Time frame: 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
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days after surgery
All-cause 30-day mortality
All-cause 30-day mortality
Time frame: At 30 days after surgery
2-year overall survival after surgery
2-year overall survival after surgery
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At the end of the 1st and 2nd years after surgery
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