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Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

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ClinicalTrials.gov Identifier: NCT06006754
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Chistos Rammos, University Hospital, Essen

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Cardiogenic Shock Microbial Colonization Out-Of-Hospital Cardiac Arrest Acute Heart Failure Acute Myocardial Infarction Other: Observational study

Study Design
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Study Type : Observational
Estimated 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
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cardiogenic shock Other: Observational study
No intervention: observational study


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between enteral microbiome composition and mortality [ Time Frame: 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 :
  1. Correlation between TMAO serum level and mortality [ Time Frame: 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

  2. Correlation between SCFA serum level and mortality [ Time Frame: 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

  3. Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006754


Contacts
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Contact: Christos Rammos, Prof. Dr. 0049201723 ext 4801 christos.rammos@uk-essen.de
Contact: Tienush Rassaf, Prof. Dr. 0049201723 ext 4801 tienush.rassaf@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, NRW, Germany, 45147
Contact: Christos Rammos, Professor    +49 (0)201-723 ext 84808    christos.rammos@uk-essen.de   
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Study Chair: Christos Rammos, Prof. Dr. University Clinic Essen
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Chistos Rammos, Professor Dr. med., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT06006754    
Other Study ID Numbers: Microbiome-Shock-Trial
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Myocardial Infarction
Out-of-Hospital Cardiac Arrest
Shock, Cardiogenic
Infarction
Shock
Heart Diseases
 Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Heart Arrest
Disease Attributes