Acute Kidney Injury Clinical Trial
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
NCT number | NCT03629418 |
Other study ID # | 2018-118 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 14, 2018 |
Est. completion date | July 2026 |
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.
Status | Recruiting |
Enrollment | 612 |
Est. completion date | July 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain severity within 3 days after surgery: NRS | 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. | Up to 3 days after surgery | |
Other | Daily prevalence of delirium during postoperative days 1-7 | Daily prevalence of delirium during postoperative days 1-7 | During the first 7 days after surgery | |
Other | Duration of intraoperative cerebral desaturation (sub-study) | 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. | During surgery | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Duration of mechanical ventilation after surgery | Duration of mechanical ventilation after surgery | Up to 30 days after surgery | |
Secondary | 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 | |
Secondary | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | All-cause 30-day mortality | All-cause 30-day mortality | At 30 days after surgery | |
Secondary | 2-year overall survival after surgery | 2-year overall survival after surgery | Up to 2 years after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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