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

NCT05111769 | Unknown

• 1 other identifier: SEPSIS-HF
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Sepsis

Keywords

sepsis; Heart Failure; AKI

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• ICU mortality and hospital mortality

  One month after entering ICU

• Mechanical ventilation time after entering ICU

  72 hours after recombinant human brain natriuretic peptide

Study Arms (2)

rhBNP in the treatment of sepsis complicated with heart failure

EXPERIMENTAL

Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure

Drug: Recombinant human brain natriuretic peptide

Conventional treatment group

NO INTERVENTION

Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure

Interventions

Recombinant human brain natriuretic peptide DRUG

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.

rhBNP in the treatment of sepsis complicated with heart failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Ju Minjie

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Sepsis; Heart Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Minjie Ju, PHD

CONTACT

8613817014079; ju.minjie@zs-hospital.sh.cn

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: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 8, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

CN (1)