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Clinical Trials/NCT06006754
NCT06006754
Completed
Not Applicable

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

University Hospital, Essen1 site in 1 country40 target enrollmentAugust 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
University Hospital, Essen
Enrollment
40
Locations
1
Primary Endpoint
Correlation between enteral microbiome composition and mortality
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2023
End Date
February 15, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Essen
Responsible Party
Principal Investigator
Principal Investigator

Chistos Rammos

Professor Dr. med.

University Hospital, Essen

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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