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NCT07617675

PHASE4

rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious perioperative complication, independently associated with prolonged hospitalization, increased mortality, and progression to chronic kidney disease. Despite advances in surgical techniques and postoperative care, no widely accepted pharmacological prevention strategy exists. Recombinant human brain natriuretic peptide (rhBNP) exerts vasodilatory, diuretic, and natriuretic effects, reduces cardiac preload and afterload, and has demonstrated safety and efficacy in treating congestive heart failure. Preliminary studies suggest rhBNP may reduce postoperative serum creatinine, increase urine output, and improve renal outcomes; however, large-scale randomized controlled evidence is lacking. The PROTECT-CS trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of perioperative continuous intravenous rhBNP infusion (0.01 μg/kg/min for 48 ± 2 hours) for prevention of AKI in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass. A total of 694 participants will be enrolled across 7 centers in China.

Official title: Perioperative Recombinant Human Brain Natriuretic Peptide for Renal Protection in Cardiac Surgery: the PROTECT-CS Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

694

Start Date

2026-05-01

Completion Date

2029-07-31

Last Updated

2026-06-01

Healthy Volunteers

Conditions

AKI - Acute Kidney Injury Cardiac Surgical Procedures Cardiopulmonary Bypass

Interventions

DRUG

Recombinant Human Brain Natriuretic Peptide (rhBNP)

Continuous intravenous infusion of rhBNP at 0.01 μg/kg/min, initiated at anesthetic induction and continued for 48 ± 2 hours. The infusion rate is consistent with the approved dosage range in the drug prescribing information.

DRUG

Normal Saline (Placebo)

Continuous intravenous infusion of normal saline at an equivalent volume and rate to the rhBNP arm, initiated at anesthetic induction and continued for 48 ± 2 hours.

Inclusion Criteria: * Age ≥ 18 years * Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass * Presence of at least one of the following AKI risk factors: * Age ≥ 70 years * Preoperative renal impairment (eGFR ≤ 60 mL/min/1.73 m² or urine protein ≥ +2 at screening) * Type 2 diabetes mellitus * Heart failure, defined as NYHA Class II-IV with NT-proBNP ≥ 125 pg/mL at screening; for participants with atrial fibrillation, NT-proBNP ≥ 365 pg/mL is required * Able to understand and provide written informed consent, and willing and able to comply with all study protocol requirements Exclusion Criteria: * Cardiogenic shock * Severe hypotension (systolic blood pressure ≤ 90 mmHg) at screening * Restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade * Preoperative chronic kidney disease stage 4 or higher (eGFR \< 30 mL/min/1.73 m²), or renal instability as judged by the investigator * Known AKI diagnosed per KDIGO criteria within 48 hours prior to surgery * Receipt of any form of renal replacement therapy within 30 days prior to surgery * Use of ventricular assist device, intra-aortic balloon pump, or any other mechanical cardiac support device within 7 days prior to surgery * Chronic hepatic insufficiency (Child-Pugh Class B or C) or hepatic dysfunction (ALT or AST \> 2× upper limit of normal \[ULN\], or total bilirubin \> 1.5× ULN) * Active hepatitis B (HBsAg positive with HBV-DNA indicating active viral replication), active hepatitis C (HCV antibody positive with HCV-RNA indicating active viral replication), positive syphilis screen, known HIV infection, or positive HIV test * Confirmed or treated endocarditis, sepsis, or active infection requiring antibiotic treatment within 30 days prior to surgery * Requirement for aortic dissection repair, complex congenital heart surgery, emergency surgery, or life-saving surgery * History of malignant tumor, solid tumor, metastatic tumor, or hematological malignancy within the past 5 years * Prior organ transplantation or current use of immunosuppressive agents * Any condition that may conflict with or contraindicate the use of intravenous vasodilator therapy * Prior adverse reaction to nesiritide (recombinant BNP) * Participation in any other clinical trial within 30 days prior to surgery * Pregnant or breastfeeding women * Any other condition that, in the judgment of the investigator, renders the participant unsuitable for study participation

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China