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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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After Cardiac Surgery Diuretic Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rhBNP group

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.

Group Type EXPERIMENTAL

rhBNP and standard basic treatment

Intervention Type 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.

control group

The control group was given positive inotropic agents, increased mean arterial pressure, restricted intake, and increased the dosage of diuretics without rhBNP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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rhBNP 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No