NCT06191146

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

Trial Health

57
Monitor

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 Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 20, 2023

Last Update Submit

February 6, 2024

Conditions

Graft FailureDialysisChronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

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

non-dialyzed kidney transplant patient hospitalized in intensive care unit

You may qualify if:

  • kidney graft
  • \> 18 years
  • first hospitalization in ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sébastien GIBOT

    CHU NANCY Central

    PRINCIPAL INVESTIGATOR

Central Study Contacts

charles ZAGOZDA

CONTACT

0684130446charles-zagozda@hotmail.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

FR(1)