Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

NCT06006754 | Completed

• 1 other identifier: Microbiome-Shock-Trial
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Microbial Colonization; Out-Of-Hospital Cardiac Arrest; Acute Heart Failure; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Correlation between enteral microbiome composition and mortality

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

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

Secondary Outcomes (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 SCFA 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 Arms (1)

Cardiogenic shock

Other: Observational study

Interventions

Observational study OTHER

No intervention: observational study

Cardiogenic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years presenting to the clinic with cardiogenic shock will be included into the study within a 24 hours timeframe after onset

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Communicable Diseases; Out-of-Hospital Cardiac Arrest

Interventions

Observation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Infections; Disease Attributes; Heart Arrest

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Christos Rammos, Prof. Dr.

  University Clinic Essen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: August 30, 2023
• Primary Completion: August 15, 2024
• Study Completion: February 15, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)