Acute Kidney Injury, Coronary Artery Bypass, Off-Pump, Intraoperative Care, Intraoperative Hypotension, Preventive Medicine
Conditions
Keywords
Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
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.
Interventions
DRUGTargeted blood-pressure management
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.
DRUGRoutine blood-pressure management
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.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury (AKI) within 7 days after surgery | Up to 7 days after surgery | Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery | Up to 30 days after surgery | MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke. |
| 2-year major adverse cardiovascular event (MACE)-free survival after surgery | Up to 2 years after surgery | MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke. |
| Cognitive function in 1- and 2-year survivors | At the end of the 1st and 2nd years after surgery | 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). |
| Quality of life in 1- and 2- year survivors: SF-36 | At the end of the 1st and 2nd years after surgery | 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. |
| Classification of AKI within 7 days after surgery | Up to 7 days after surgery | Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria |
| Incidence of delirium within 7 days after surgery | Up to 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). |
| Duration of mechanical ventilation after surgery | Up to 30 days after surgery | Duration of mechanical ventilation after surgery |
| Length of stay in intensive care unit (ICU) after surgery | Up to 30 days after surgery | Length of stay in intensive care unit (ICU) after surgery |
| Length of stay in hospital after surgery | Up to 30 days after surgery | Length of stay in hospital after surgery |
| Incidence of non-MACE complications within 30 days after surgery | Up to 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. |
| All-cause 30-day mortality | At 30 days after surgery | All-cause 30-day mortality |
| 2-year overall survival after surgery | Up to 2 years after surgery | 2-year overall survival after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of intraoperative cerebral desaturation (sub-study) | During surgery | Duration of cerebral desaturation is monitored by near-infrared spectroscopy. Cerebral desaturation is defined as a decrease of more than 10% from baseline. Performed in part of enrolled patients. |
| Daily prevalence of delirium during postoperative days 1-7 | During the first 7 days after surgery | Daily prevalence of delirium during postoperative days 1-7 |
| Pain severity within 3 days after surgery: NRS | Up to 3 days after surgery | Pain severity is assessed with the Numeric Rating Scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00-10:00 am, 18:00-20:00 pm) after surgery. |
Countries
China
Contacts
Primary ContactDong-Xin Wang, MD, PhD
Backup ContactLi Huang, MD, PhD
Outcome results
None listed