Evaluation of the Efficacy of rhBNP in Patients With Diuretic Resistance After Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: After Cardiac Surgery; Diuretic Resistance
• Interventions: Drug: rhBNP and standard basic treatment

• Registration Number: NCT07086287
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

Brief Summary

evaluation of the efficacy of recombinant human brain natriuretic peptide in patients with diuretic resistance after cardiac surgery: a prospective single-center single-blind randomized controlled study

Detailed Description

Postoperative adult patients (aged ≥18 years) with fluid overload were randomly assigned to groups, divided into the rhBNP group and the control group. The control group received positive inotropic agents, increased mean arterial pressure, restricted fluid intake, and increased the dosage of diuretics. The rhBNP group received conventional treatment in addition to a loading dose of 1.5-2 μg/kg intravenously, according to the instructions, to maintain a dosage of 0.0075-0.01 μg/kg/min continuously infused via intravenous pump for 72 hours, with dosage adjusted based on blood pressure. The grouping of subjects was concealed, and researchers were not allowed to access grouping information before the analysis was completed, with early unblinding prohibited. The primary research endpoint was the incidence of renal replacement therapy. Secondary research endpoints included the duration of tracheal intubation after cardiac surgery, CICU time after cardiac surgery, and length of hospitalization after cardiac surgery. Blood and urine samples were collected at the time of enrollment, 1 hour after maintaining the rhBNP dosage of 0.0075-0.01 μg/kg/min, and at 24 hours, 48 hours, and 72 hours after medication administration.

Study Timeline

• Study First Submitted: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-08-01
• Primary Completion: 2026-11-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• (1) Adult patients after cardiac surgery (age ≥ 18 years) (2) Fluid overload (3) Diuretic resistance Definition: Daily intravenous use of furosemide at a dose ≥ 80mg or equivalent doses of other diuretics, yet still unable to achieve an adequate urine output of 0.5~1.0mL/kg/h. Conversion formula for different loop diuretics: Oral furosemide 80mg = Intravenous furosemide 40mg = Oral/Intravenous torsemide 20mg = Oral/Intravenous bumetanide 1mg (4) Willing to participate in the trial and sign the informed consent form.

Exclusion Criteria

• (1) Preoperative CKD patients undergo regular dialysis treatment; (2) Postoperative use of CRRT; (3) Drug allergies involved in this study; (4) Those with corrected systolic blood pressure still < 90 mmHg after vasopressor use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhBNP group	rhBNP and standard basic treatment	The rhBNP group was given positive inotropic agents, increased mean arterial pressure, restricted intake, and increased the dosage of diuretics. At the same time, rhBNP will be administered a venous loading dose of 1.5\~2μg/kg, refer to the instructions for a maintenance dose of 0.0075-0.01μg/kg/min for continuous intravenous infusion for 72 hours.

Primary Outcome Measures

Name	Time	Method
the incidence of renal replacement therapy	From enrollment to discharge: at enrollment, the maintenance dose of rhBNP is 0.0075-0.01ug/kg/min, after 1 hour, 24 hours, 48 hours, and 72 hours post-medication.	Indications for initiating renal replacement therapy (RRT): (1) Severe electrolyte disturbances, such as blood potassium \>6.5 mmol/L with ECG abnormalities, or ineffective drug treatment; (2) Metabolic acidosis, pH \<7.15 and HCO₃-\<12 mmol/L, excluding respiratory factors; (3) Volume overload, pulmonary edema/persistent heart failure, and unresponsive to diuretics (e.g., urine output \<200ml/2h during furosemide stress test positive); (4) Toxin removal, rhabdomyolysis (creatine kinase (CK) \> 5000 U/L with acute kidney injury).

Trial Locations

Locations (1)

the First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China