Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites 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.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Acute Myocardial Infarction; Cardiogenic Shock; Out-Of-Hospital Cardiac Arrest; Acute Heart Failure
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Christos Rammos, Prof. Dr.; Phone Number: 4801 0049201723; Email: christos.rammos@uk-essen.de
• Study Contact Backup: Name: Tienush Rassaf, Prof. Dr.; Phone Number: 4801 0049201723; Email: tienush.rassaf@uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • Recruiting
      • University Hospital Essen
      • Contact: Christos Rammos, Professor; Phone Number: 84808 +49 (0)201-723; Email: christos.rammos@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiogenic shock	Other: Observational study; No intervention: observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between TMAO serum level and mortality	Blood samples are collected at below mentioned time points	Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
Correlation between SCFA serum level and mortality	Blood samples are collected at below mentioned time points	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	Blood samples are collected at below mentioned time points	Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Study Chair: Christos Rammos, Prof. Dr., University Clinic Essen

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Heart Arrest; Myocardial Infarction; Infarction; Infections; Communicable Diseases; Shock; Shock, Cardiogenic; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: Microbiome-Shock-Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No