Factors for Impairment of Renal Graft Function in Intensi... | NCT06191146

Studies
Factors for Impairment of Renal Graft Function in Intensive Care

NCT06191146

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Feb 8, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Graft Failure
Dialysis
Chronic Kidney Failure

Interventions

Not provided

Countries

France

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

Feb 2024

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

Jan 1, 2024Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Dec 20, 2023

First Submission Date that Met QC Criteria

Dec 20, 2023

First Posted Date

Jan 5, 2024Actual

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

Feb 6, 2024

Last Update Posted Date

Feb 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gibot Sébastien, Professor, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed.

the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization.

Optimization of renal graft management in the ICU and management by nephrologists after the ICU

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
composite: return to dialysis, decline in GFR < 15 ml/min, death at 2 years	Death within 2 years, glomerular filtration rate < 15mL/min, need for dialysis	2 years after ICU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

kidney graft
> 18 years
first hospitalization in ICU

Exclusion Criteria:

chronic hemodialysis before ICU
transfer to intensive care immediately after transplant within 24 hours

Accepts Healthy Volunteers

Yes

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

non-dialyzed kidney transplant patient hospitalized in intensive care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
charles ZAGOZDA	Contact	0684130446		charles-zagozda@hotmail.fr

Overall Officials

Name	Affiliation	Role
Sébastien GIBOT	CHU NANCY Central	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy	Recruiting	Nancy			France

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided