About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass
Age ≥ 70 years
Preoperative renal impairment (eGFR ≤ 60 mL/min/1.73 m² or urine protein ≥ +2 at screening)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Recombinant Human Brain Natriuretic Peptide (rhBNP)
- Normal Saline (Placebo)
Treatment groups
Sponsors and collaborators
China National Center for Cardiovascular Diseases
Lead sponsor
The First Affiliated Hospital of Xiamen University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Shenzhen Sun Yat-sen Cardiovascular Hospital
Collaborator