Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Sponsor

University Hospital, Essen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006754

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Microbial Colonization Out-Of-Hospital Cardiac Arrest Acute Heart Failure Acute Myocardial Infarction	Other: Observational study

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cardiogenic shock	Other: Observational study No intervention: observational study

Arm

Intervention/Treatment

Cardiogenic shock

Other: Observational study

No intervention: observational study

Outcome Measures

Primary Outcome Measures

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

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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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