CompletedNot Applicable

Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Germany40 participantsStarted 2023-08-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between enteral microbiome composition and mortality

Timeframe: Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month

Trial details

NCT IDNCT06006754

SponsorUniversity Hospital, Essen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Cardiogenic Shock trials