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

What Was Tested

The trial (phase 4) is built around BNP (Nesiritide).

It had two arms (groups): rhBNP Treatment Group (experimental) and Placebo Control Group (placebo comparator).

Participants receive continuous intravenous infusion of normal saline at an equivalent rate and volume, initiated from anesthetic induction to the onset of cardiopulmonary bypass, administered continuously for 48 ± 2 hours. All participants receive standard perioperative cardiac surgical care.

The registry classes the interventions as drug.

More on the Plan

Acute kidney injury (AKI) is one of the most common and serious complications following cardiac surgery.

Recombinant human brain natriuretic peptide (rhBNP, generic name: nesiritide) shares structural and biological activity highly similar to endogenous BNP.

The PROTECT-CS trial aims to address this evidence gap.

Eligible participants are adults aged ≥18 years scheduled for elective cardiac surgery under cardiopulmonary bypass who have at least one AKI risk factor (age ≥70 years, preoperative renal impairment, type 2 diabetes mellitus, or heart failure).

Who Took Part

The registry lists 694 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass. Presence of at least one of the following AKI risk factors:. Age ≥ 70 years. Type 2 diabetes mellitus.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: cardiogenic shock; severe hypotension (systolic blood pressure ≤ 90 mmhg) at screening; restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-05-01 with completion listed for 2028-01-31.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria (time frame: Within 7 days after surgery, or until hospital discharge if earlier).

It also tracked 21 secondary outcomes, for example Incidence of AKI within 72 hours postoperatively, diagnosed according to KDIGO criteria, Duration of AKI by KDIGO criteria, Severity of AKI by KDIGO stage, Change in serum creatinine from preoperative baseline, Change in urinary creatinine from preoperative baseline and Change in estimated glomerular filtration rate (eGFR) from preoperative baseline.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 694 people.

With 694 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, all human trials.