Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Recruiting

• Conditions: Cardiogenic Shock; Out-Of-Hospital Cardiac Arrest; Acute Heart Failure; Microbial Colonization; Acute Myocardial Infarction
• Interventions: Other: Observational study

• Registration Number: NCT06006754
• Lead Sponsor: University Hospital, Essen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-08-30
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiogenic shock	Observational study	-

Primary Outcome Measures

Name	Time	Method
Correlation between enteral microbiome composition and mortality	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 Outcome Measures

Name	Time	Method
Correlation between SCFA serum level and mortality	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
Correlation between TMAO serum level and mortality	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
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	Blood samples are collected at below mentioned time points

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany