rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) (NCT07617675) | Clinical Trial Compass
Not Yet RecruitingPhase 4
rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)
China694 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically testing whether rhBNP can prevent acute kidney injury after cardiac surgery involving cardiopulmonary bypass, can you help me understand whether my kidneys are at enough risk during my planned surgery to make this kind of protection worth exploring?
2This trial is Phase 4, which means rhBNP has already been through earlier safety testing — but it's being studied in this specific kidney-protection role for the first time at this scale, so what do you already know about how rhBNP behaves in patients like me, and what risks should I still be aware of?
3The trial is measuring whether acute kidney injury develops within 7 days after surgery using a specific standard called KDIGO criteria — can you explain what that means for my monitoring and hospital stay, and how that compares to what I'd experience outside a trial?
4Since this trial says it is not yet recruiting, what is the realistic timeline before it might open, and should I be making decisions about my surgery now rather than waiting to see if I could participate?
5Are there already standard-of-care strategies your team uses to protect my kidneys during cardiac surgery, and how would participating in this trial compare to or interact with those approaches?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria
Timeframe: Within 7 days after surgery, or until hospital discharge if earlier
Trial details
NCT IDNCT07617675
SponsorChina National Center for Cardiovascular Diseases