Health TrialsbyHealthPanel

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

ConditionsAKI - Acute Kidney InjuryCardiac Surgical ProceduresCardiopulmonary Bypass
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Recombinant Human Brain Natriuretic Peptide (rhBNP)

    Drug

    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.

  • Normal Saline (Placebo)

    Drug

    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.

Treatment groups

694 Participants
are divided into 2 treatment groups
Group A: rhBNP Treatment GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria

AKI defined per KDIGO 2012 criteria as any of: (1) serum creatinine increase ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; (2) serum creatinine increase to ≥ 1.5 times baseline within 7 days; or (3) urine output \< 0.5 mL/kg/h for ≥ 6 consecutive hours. If a participant is discharged earlier than postoperative day 7, AKI events occurring in-hospital are recorded.

Time frame
Within 7 days after surgery, or until hospital discharge if earlier

Secondary outcomes

1

Incidence of AKI within 72 hours postoperatively, diagnosed according to KDIGO criteria

Time frame
Within 72 hours after surgery
2

Duration of AKI by KDIGO criteria

Duration of AKI among participants who develop AKI within 7 days postoperatively, recorded in hours from onset to resolution per KDIGO criteria. If a participant is discharged earlier than postoperative day 7, in-hospital AKI events are recorded.

Time frame
Within 7 days after surgery, or until hospital discharge if earlier
3

Severity of AKI by KDIGO stage

Distribution of participants across KDIGO Stage 1, Stage 2, and Stage 3, based on the maximum stage reached. If a participant is discharged earlier than postoperative day 7, in-hospital AKI events are recorded.

Time frame
Within 7 days after surgery, or until hospital discharge if earlier
4

Incidence of any form of renal replacement therapy (RRT) during the index hospitalization

Number of participants receiving any form of RRT (intermittent hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) during the surgical hospitalization.

Time frame
During the index hospitalization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: