Observing gut health in critically ill patients with liver disease
Secondary Sclerosing Cholangitis in Critically Ill Patients (SC-CIP): A Prospective Cohort Study
This study looks at the gut health of critically ill patients with liver disease to see how it might affect their condition and help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT03566797 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the gut microbiome composition, gut permeability, bacterial translocation, inflammation, bile acid composition, and genetic polymorphisms in patients at high risk of developing secondary sclerosing cholangitis in critically ill settings. It focuses on patients who have undergone long-term treatment in intensive care units and explores the unclear pathogenesis of this rapidly progressive liver disease. By conducting a prospective cohort study, researchers hope to gather valuable data that could lead to better understanding and management of this condition.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients over 18 years old who have been on mechanical ventilation or extracorporeal membrane oxygenation for at least 5 days.
Not a fit: Patients with a prior diagnosis of primary or secondary sclerosing cholangitis before their current ICU admission will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that improve the diagnosis and treatment of secondary sclerosing cholangitis in critically ill patients.
How similar studies have performed: While the specific approach of this study is novel, similar studies have explored gut health in critically ill patients, indicating potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study OR "surrogate consent" by the institutional review board. * Age above 18 years * Mechanical ventilation or extracorporeal membrane oxygenation \>/= 5 days Exclusion Criteria: * Primary or secondary sclerosing cholangitis diagnosed before current ICU admission
Where this trial is running
Graz
- Medical University Graz — Graz, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.