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

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.

NCT Number	NCT07617675
Lead Sponsor	China National Center for Cardiovascular Diseases Collaborators: The First Affiliated Hospital of Xiamen University, Guangdong Provincial People's Hospital, Yantai Yuhuangding Hospital, Second Xiangya Hospital of Central South University, First Affiliated Hospital of Chongqing Medical University, Shenzhen Sun Yat-sen Cardiovascular Hospital
Conditions	AKI - Acute Kidney Injury, Cardiac Surgical Procedures, Cardiopulmonary Bypass
Enrollment	694 participants
Start Date	2026-05-01
Primary Completion	2028-01-31 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-01