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临床试验/NCT06006754
NCT06006754已完成不适用

Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites on Mortality of Patients With Cardiogenic Shock

University Hospital, Essen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Correlation between enteral microbiome composition and mortality

研究概览

简要总结

Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. The significance of the enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not known.

This study aims to provide a deeper understanding of the role of the enteral microbiome and microbiome dependent metabolites in mortality and disease progression of patients with cardiogenic shock.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • signs of cardiogenic shock regardless of etiology
  • lactate >3mmol/L
  • and signs of organ dysfunction (urine output <30 ml/h, cold extremities, altered mental status)
  • and systolic blood pressure <90 mmHg for >30 minutes or need for vasopressor therapy

排除标准

  • pregnancy/lactation period
  • antibiotic treatment within >24h
  • chronic inflammatory bowel disease
  • short bowel syndrome
  • artificial bowel outlet
  • persistent diarrhea or vomiting in the past 3 months
  • simultaneous participation in another interfering nutrition study
  • active chemo or radiation therapy

结局指标

主要结局

Correlation between enteral microbiome composition and mortality

时间窗: Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month

Stool samples are collected and clinical evaluation will be performed at below mentioned time points

次要结局

  • Correlation between SCFA serum level and mortality(Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3)
  • Correlation between TMAO serum level and mortality(Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3)
  • Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality(Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chistos Rammos

Professor Dr. med.

University Hospital, Essen

研究点 (1)

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