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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06006754
Enrollment
40
Registered
2023-08-23
Start date
2023-08-30
Completion date
2025-02-15
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERObservational study

No intervention: observational study

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between enteral microbiome composition and mortalitySampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 monthStool samples are collected and clinical evaluation will be performed at below mentioned time points

Secondary

MeasureTime frameDescription
Correlation between TMAO serum level and mortalitySampling will be performed within 24 hours of onset of cardiogenic shock and on day 3Blood samples are collected at below mentioned time points
Correlation between SCFA serum level and mortalitySampling will be performed within 24 hours of onset of cardiogenic shock and on day 3Blood samples are collected at below mentioned time points
Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortalitySampling will be performed within 24 hours of onset of cardiogenic shock and on day 3Blood samples are collected at below mentioned time points

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026