LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME

• Conditions: ICU Patients

• Registration Number: NCT04067271
• Lead Sponsor: University of Luebeck

Brief Summary

The purpose of the current study is to analyze the effects of ICU-care on changes in microbiome and the influence of intestinal microbiome changes on short-term and long-term morbidity and mortality of ICU patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2024-03-18
• Study Completion: 2024-03-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥18 years
• All patients receiving intensive medical care
• A written informed consent from the patient or two independent doctors or legal guardians.

Exclusion Criteria

• Age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modification of the microbiome	Day 0	The modification of the microbiome using ribosomal 16 S DNA sequencing and clustering for Operational Taxonomic Units (OTU) and calculated Shannon Index

Secondary Outcome Measures

Name	Time	Method
ICU intensive care unit stay	Day 0	Duration
Hospital stay	Month 6	Duration
Survival	Month 12	To discharge

Trial Locations

Locations (1)

Medical Clinic II-UKSH Campus Lübeck; 🇩🇪 Luebeck, Schleswig-Holstein, Germany