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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBNP group | Experimental | 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. |
|
| control group | No Intervention | The control group was given positive inotropic agents, increased mean arterial pressure, restricted intake, and increased the dosage of diuretics without rhBNP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qian gong | Contact | +86-18226616000 | 54xiaoqian@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38188212 | Result | Kourek C, Briasoulis A, Giamouzis G, Skoularigis J, Xanthopoulos A. Lyophilized recombinant human brain natriuretic peptide: A promising therapy in patients with chronic heart failure. World J Clin Cases. 2023 Dec 26;11(36):8603-8605. doi: 10.12998/wjcc.v11.i36.8603. | |
| 37933155 | Result | Li X, Wang R, Sun D, Yao Y, Wang T, Luo G, Liu M, Xu J, Cheng Z, Gao Q, Wang Y, Wu C, Xu G, Lv T, Zou J, Yan M. Risk Factors for Hypocoagulability After Cardiac Surgery: A Retrospective Study. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231209927. doi: 10.1177/10760296231209927. |
| Label | URL |
|---|---|
| China Clinical Trial Registration Center | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| rhBNP | Study Protocol | View IPD |
2030-01-01 Publication of academic papers
Starting from 2023-01-01, permanently.
Access researchers from the China Clinical Trial Registry or clinicaltrials.gov .
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| 30835094 | Result | Thanavaro J, Taylor J, Vitt L, Guignon MS. Predictors and Outcomes of Acute Kidney Injury after Cardiac Surgery. Nephrol Nurs J. 2019 Jan-Feb;46(1):31-40. |
| 26739721 | Result | Gong B, Wu Z, Li Z. Efficacy and safety of nesiritide in patients with decompensated heart failure: a meta-analysis of randomised trials. BMJ Open. 2016 Jan 6;6(1):e008545. doi: 10.1136/bmjopen-2015-008545. |
| 19808265 | Result | Yancy CW, Krum H, Massie BM, Silver MA, Stevenson LW, Cheng M, Kim SS, Evans R; FUSION II Investigators. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Circ Heart Fail. 2008 May;1(1):9-16. doi: 10.1161/CIRCHEARTFAILURE.108.767483. |
| 38485428 | Result | Wang H, Li Y, Chai K, Long Z, Yang Z, Du M, Wang S, Zhan S, Liu Y, Wan Y, Wang F, Yin P, Li W, Liao Y, Dong Y, Li X, Zhou J, Yiu KH, Zhou M, Huo Y, Yang J. Mortality in patients admitted to hospital with heart failure in China: a nationwide Cardiovascular Association Database-Heart Failure Centre Registry cohort study. Lancet Glob Health. 2024 Apr;12(4):e611-e622. doi: 10.1016/S2214-109X(23)00605-8. |
China Clinical Trial Registration Center |