Evaluation of the Efficacy of rhBNP in Patients With Diuretic Resistance After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rhBNP and standard basic treatment.
- Who it may be relevant to
- Registry conditions: After Cardiac Surgery, Diuretic Resistance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug 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.
Primary outcome measures
- the incidence of renal replacement therapy [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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital of Anhui Medical University — Hefei
Publications
- 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. PMID 38188212
- 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. PMID 37933155
- 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. PMID 30835094
- 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. PMID 26739721
- 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. PMID 19808265
- 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- PMID 38485428
Identifiers
NCT: NCT07086287 · rhBNP with diuretic resistance