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

NCT ID: NCT05111769

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Sepsis

Keywords

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sepsis Heart Failure AKI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rhBNP in the treatment of sepsis complicated with heart failure

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

Group Type EXPERIMENTAL

Recombinant human brain natriuretic peptide

Intervention Type 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.

Conventional treatment group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ju Minjie

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Minjie Ju, PHD

Role: CONTACT

Phone: 8613817014079

Email: [email protected]

Other Identifiers

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SEPSIS-HF

Identifier Type: -

Identifier Source: org_study_id