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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

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

694 Participants
are divided into 2 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