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

NCT07086287 | Not Yet Recruiting DMC

• 1 other identifier: rhBNP with diuretic resistance
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

After Cardiac Surgery; Diuretic Resistance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Drug: rhBNP and standard basic treatment

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.

Interventions

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.

rhBNP group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Related Publications (6)

• 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 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.

  PMID: 37933155 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.

  PMID: 30835094 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.

  PMID: 26739721 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.

  PMID: 19808265 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.

  PMID: 38485428 RESULT

Related Links

• China Clinical Trial Registration Center

Central Study Contacts

qian gong

CONTACT

+86-18226616000; 54xiaoqian@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting from 2023-01-01, permanently.
• Access Criteria: Access researchers from the China Clinical Trial Registry or clinicaltrials.gov .

Locations

CN (1)