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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • rhBNP and standard basic treatment

    Drug

    After administering a bolus of rhBNP at 1.5-2 μg/kg intravenously, a maintenance dose of 0.0075-0.01 μg/kg/min is continuously infused intravenously for 72 hours, with the dosage adjusted based on blood pressure and heart rate; the control group receives standard basic treatment.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: rhBNP groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

the incidence of renal replacement therapy

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).

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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