LUEbeck Registry of Intensive Care Patients - Characteriz... | NCT04067271

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

NCT04067271

Sponsor

University of Luebeck

Status

Unknown status

Last Update Posted

May 18, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

ICU Patients

Interventions

Analyze changes in intestinal microbiome

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2019Actual

Primary Completion Date

Mar 18, 2024Estimated

Completion Date

Mar 18, 2024Estimated

First Submitted Date

Aug 21, 2019

First Submission Date that Met QC Criteria

Aug 21, 2019

First Posted Date

Aug 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analyze changes in intestinal microbiome	Other	Descriptive Analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
ICU intensive care unit stay	Duration	Day 0
Hospital stay	Duration	Month 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who receive treatment on ICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Graf, MD	Contact	+49 451 500 75306		tobias.graf@uksh.de
Roza Meyer-Saraei, PhD	Contact	+49 451 500 44542		roza.meyer-saraei@uksh.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Clinic II-UKSH Campus Lübeck	Recruiting	Lübeck	Schleswig-Holstein	23562	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000069196	Gastrointestinal Microbiome

Ancestor Terms

ID	Term
D064307	Microbiota
D008827	Microbiological Phenomena
D058448	Biota
D044822	Biodiversity

Browse Leaves

Not provided

Browse Branches

Not provided