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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05111769
Enrollment
70
Registered
2021-11-08
Start date
2021-12-01
Completion date
2023-12-01
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, Heart Failure, AKI

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.

Interventions

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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function72 hours after rhBNPThe decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group72 hours after recombinant human brain natriuretic peptideThe improvement degree of cardiac index in recombinant human brain natriuretic peptide group

Secondary

MeasureTime frameDescription
ICU mortality and hospital mortalityOne month after entering ICUComparison between rhBNP group and control group
Mechanical ventilation time after entering ICU72 hours after recombinant human brain natriuretic peptideComparison between rhBNP group and control group

Countries

China

Contacts

Primary ContactMinjie Ju, PHD
ju.minjie@zs-hospital.sh.cn8613817014079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026