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临床试验/NCT05111769
NCT05111769Unknown不适用

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

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

rhBNP in the treatment of sepsis complicated with heart failure

Experimental

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

干预措施: Recombinant human brain natriuretic peptide (Drug)

结局指标

主要结局

PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group

时间窗: 72 hours after recombinant human brain natriuretic peptide

The improvement degree of cardiac index in recombinant human brain natriuretic peptide group

the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function

时间窗: 72 hours after rhBNP

The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)

次要结局

  • ICU mortality and hospital mortality(One month after entering ICU)
  • Mechanical ventilation time after entering ICU(72 hours after recombinant human brain natriuretic peptide)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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