the First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
NCT Number: NCT07086287
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Hefei, Anhui, 230000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Anhui Medical University
Other
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
Acronym: rhBNP
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