NCT04067271

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

August 21, 2019

Last Update Submit

May 17, 2022

Conditions

ICU Patients

Outcome Measures

Primary Outcomes (1)

  • Modification of the microbiome

    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 Outcomes (5)

  • ICU intensive care unit stay

    Day 0

  • Hospital stay

    Month 12

  • Hospital stay

    Month 6

  • Survival

    Month 6

  • Survival

    Month 12

Interventions

Analyze changes in intestinal microbiomeOTHER

Descriptive Analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive treatment on ICU.

You may qualify if:

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

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Clinic II-UKSH Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

RECRUITING

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Central Study Contacts

Tobias Graf, MD

CONTACT

+49 451 500 75306tobias.graf@uksh.de

Roza Meyer-Saraei, PhD

CONTACT

+49 451 500 44542roza.meyer-saraei@uksh.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

March 18, 2019

Primary Completion

March 18, 2024

Study Completion

March 18, 2024

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

DE(1)