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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07086287
Acronym
rhBNP
Enrollment
120
Registered
2025-07-25
Start date
2025-08-01
Completion date
2028-06-30
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

After Cardiac Surgery, Diuretic Resistance

Keywords

recombinant human brain natriuretic peptide, diuretic resistance, after cardiac surgery, the incidence of renal replacement therapy

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.

Interventions

DRUGrhBNP and standard basic treatment

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.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the incidence of renal replacement therapyFrom 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).

Countries

China

Contacts

Primary Contactqian gong
54xiaoqian@sina.com+86-18226616000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026