Cardiogenic ShockNCT06006754
Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock
An observational study of Cardiogenic Shock and Microbial Colonization, run by University Hospital, Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Microbial Colonization, Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Observational study
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 30 Aug 2023to 15 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites on Mortality of Patients With Cardiogenic Shock
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.
- Conditions
- Cardiogenic Shock, Microbial Colonization, Out-Of-Hospital Cardiac Arrest, Acute Heart Failure, Acute Myocardial Infarction
- Being tested
- Observational study
- Medical subject headings
- Shock, Cardiogenic, Communicable Diseases, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention: observational study
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic shock | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between enteral microbiome composition and mortality
Stool samples are collected and clinical evaluation will be performed at below mentioned time points
Measured: Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month
Secondary outcomes (3)
Correlation between TMAO serum level and mortality
Blood samples are collected at below mentioned time points
Measured: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
Correlation between SCFA serum level and mortality
Blood samples are collected at below mentioned time points
Measured: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality
Blood samples are collected at below mentioned time points
Measured: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start30 Aug 2023
- Primary completion15 Aug 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chistos Rammos, University Hospital, Essen
- Investigators
- Christos Rammos, Prof. Dr., Study chair, University Clinic Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006754
- Sponsor's protocol ID
- Microbiome-Shock-Trial
- Status last verified
- Jun 2025
- First submitted
- 17 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites on Mortality of Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT06006754
- Acronym / sponsor ID
- Microbiome-Shock-Trial
- Conditions
- Cardiogenic Shock, Microbial Colonization, Out-Of-Hospital Cardiac Arrest, Acute Heart Failure, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic shock | – | Other: Observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- >18y
- signs of cardiogenic shock regardless of etiology
Key exclusion criteria (8 listed)
- pregnancy/lactation period
- antibiotic treatment within >24h
- chronic inflammatory bowel disease
- short bowel syndrome
- artificial bowel outlet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNo intervention: observational study | Other | Cardiogenic shock |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
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Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
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Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
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Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
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RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos Rammos, Prof. Dr. study chair
University Clinic Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Microbial Colonization, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.