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

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Fudan University

Status

Unknown

Conditions

Sepsis

Treatments

Drug: Recombinant human brain natriuretic peptide

Study type

Interventional

Funder types

Other

Identifiers

NCT05111769
SEPSIS-HF

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

rhBNP in the treatment of sepsis complicated with heart failure
Experimental group
Description:
Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure
Treatment:
Drug: Recombinant human brain natriuretic peptide
Conventional treatment group
No Intervention group
Description:
Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure

Trial contacts and locations

1

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Central trial contact

Minjie Ju, PHD

Data sourced from clinicaltrials.gov

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