Skip to main content
OpenTrials
Completed

NCT Number: NCT06006754

Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiogenic Shock Acute Heart Failure Acute Myocardial Infarction Cardiovascular Diseases Communicable Diseases Disease Attributes Heart Arrest Heart Diseases Infarction Infections Ischemia Microbial Colonization Myocardial Infarction Myocardial Ischemia Necrosis Out-Of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18y
  • 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

Exclusion criteria

  • 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

Treatment and study plan

observational study

Other

No intervention: observational study

Primary outcomes

  1. Correlation between enteral microbiome composition and mortality

    Time frame: 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

Secondary outcomes

  1. Correlation between TMAO serum level and mortality

    Time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3

    Blood samples are collected at below mentioned time points

  2. Correlation between SCFA serum level and mortality

    Time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3

    Blood samples are collected at below mentioned time points

  3. Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality

    Time frame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3

    Blood samples are collected at below mentioned time points

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.