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

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.

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Shenzhen Sun Yat-sen Cardiovascular Hospital

  collaborator OTHER

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Principal Investigators

• Sheng Liu · Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-01-31

Completion

2029-07-31

Countries

• China

Study Locations