Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure

Not Applicable

• Conditions: Sepsis
• Interventions: Drug: Recombinant human brain natriuretic peptide

• Registration Number: NCT05111769
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The investigators intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction

Detailed Description

Sepsis is one of the common critical diseases in ICU with high mortality. Septic shock patients are often accompanied by multiple organ dysfunction (MODS), of which more than 50% of patients with varying degrees of myocardial injury.The investigators hope to find a drug with a protective effect on cardiac function and kidney function, so as to treat sepsis more effectively in the treatment of sepsis.

Recombinant human brain natriuretic peptide (rhBNP) was approved by FDA in 2001 for the treatment of acute decompensated heart failure.These effects play a role in the protection of cardiac and kidney function, and have achieved good results in patients with cardiac insufficiency and AKI caused by cardiac surgery.

The investigators are going to carry out related research from the following aspects: 1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.

Study Timeline

• Study First Submitted: 2021-09-30
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Study Start: 2021-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• sepsis complicated with heart failure（Diagnosed by sepsis 3.0）
• Heart failure: BNP rises by 600 pg/ml
• Age>=18 years old

Exclusion Criteria

• Hemodynamically unstable
• Pregnant
• Disagree with comprehensive and active life support treatment
• coronary heart disease, myocardial infarction, and cardiac insufficiency
• chronic renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhBNP in the treatment of sepsis complicated with heart failure	Recombinant human brain natriuretic peptide	Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure

Primary Outcome Measures

Name	Time	Method
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group	72 hours after recombinant human brain natriuretic peptide	The improvement degree of cardiac index in recombinant human brain natriuretic peptide group
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function	72 hours after rhBNP	The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)

Secondary Outcome Measures

Name	Time	Method
ICU mortality and hospital mortality	One month after entering ICU	Comparison between rhBNP group and control group
Mechanical ventilation time after entering ICU	72 hours after recombinant human brain natriuretic peptide	Comparison between rhBNP group and control group

Trial Locations

Locations (1)

Ju Minjie; 🇨🇳 Shanghai, Shanghai, China