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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05111769
• Other study ID #: SEPSIS-HF
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Minjie Ju, PHD
• Phone: 8613817014079
• Email: ju.minjie[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Sepsis
• Toxemia

Intervention

Drug:
• Recombinant human brain natriuretic peptide
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.

Locations

Country	Name	City	State
China	Ju Minjie	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function	The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)	72 hours after rhBNP
Primary	PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group	The improvement degree of cardiac index in recombinant human brain natriuretic peptide group	72 hours after recombinant human brain natriuretic peptide
Secondary	ICU mortality and hospital mortality	Comparison between rhBNP group and control group	One month after entering ICU
Secondary	Mechanical ventilation time after entering ICU	Comparison between rhBNP group and control group	72 hours after recombinant human brain natriuretic peptide