LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME (LUERIC-M)

May 17, 2022 updated by: Dr. med. Tobias Graf, University of Luebeck
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23562
        • Recruiting
        • Medical Clinic II-UKSH Campus Lübeck
        • Contact:
          • Tobias Graf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive treatment on ICU.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of the microbiome
Time Frame: Day 0
The modification of the microbiome using ribosomal 16 S DNA sequencing and clustering for Operational Taxonomic Units (OTU) and calculated Shannon Index
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU intensive care unit stay
Time Frame: Day 0
Duration
Day 0
Hospital stay
Time Frame: Month 12
Duration
Month 12
Hospital stay
Time Frame: Month 6
Duration
Month 6
Survival
Time Frame: Month 6
To discharge
Month 6
Survival
Time Frame: Month 12
To discharge
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Anticipated)

March 18, 2024

Study Completion (Anticipated)

March 18, 2024

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 19-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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