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

Study Overview
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Recombinant human brain natriuretic peptide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBNP in the treatment of sepsis complicated with heart failure<br>Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure | Drug: Recombinant human brain natriuretic peptide<br>* 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.<br>|
| No Intervention: Conventional treatment group<br>Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality and hospital mortality | Comparison between rhBNP group and control group | One month after entering ICU | 
| Mechanical ventilation time after entering ICU | Comparison between rhBNP group and control group | 72 hours after recombinant human brain natriuretic peptide | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AKI, sepsis, Heart Failure