Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006754
• Other study ID #: Microbiome-Shock-Trial
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Essen
• Contact: Christos Rammos, Prof. Dr.
• Phone: 0049201723
• Email: christos.rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Acute Myocardial Infarction
• Cardiogenic Shock
• Communicable Diseases
• Infarction
• Infections
• Microbial Colonization
• Myocardial Infarction
• Out-of-Hospital Cardiac Arrest
• Shock
• Shock, Cardiogenic

Intervention

Other:
• Observational study
No intervention: observational study

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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