NCT07317362

Brief Summary

The goal of this observational study is to evaluate when renal replacement therapy (RRT) can be safely discontinued in intensive care unit (ICU) patients with acute kidney injury (AKI). The main question it aims to answer is: Can the UNDERSCORE predictive score accurately identify ICU patients with AKI who can successfully stop RRT without needing restart or experiencing early death? Using routinely collected clinical data from the AP-HP Health Data Warehouse, the study will follow ICU patients with AKI treated with RRT to assess whether the UNDERSCORE score predicts successful RRT discontinuation within 7 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,976

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 19, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

26 days

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful weaning from renal replacement therapy

    absence of RRT resumption or death within 7 days

    7 days

Secondary Outcomes (3)

  • 28-day mortality

    28 days from RRT weaning attempt

  • 60 day-mortality

    Death within 60 days of RRT weaning attempt

  • Renal function recovery

    7 days from RRT weaning attempt

Study Arms (1)

Study cohort

APHP adults patients (\>=18 yeays-old) admitted to the intensive care unit with severe acute kidney injury (defined as KDIGO stage 2 or 3) who received renal replacement therapy (RRT).

Other: Discontinuation of renal replacement therapy

Interventions

Discontinuation of renal replacement therapy is defined as the absence of RRT resumption within 3 days for intermittent RRT, and as definitive cessation for continuous RRT.

Study cohort

Eligibility Criteria

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

Adult patients admitted to the intensive care unit with severe acute kidney injury who received renal replacement therapy (RRT)

You may qualify if:

  • Patients admitted to the intensive care unit with severe acute kidney injury (defined as KDIGO stage 2 or 3) who received renal replacement therapy (RRT).

You may not qualify if:

  • Patients under the age of 18, those without electronical medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Clinique Paris Saclay

Le Kremlin-Bicêtre, 94270, France

Location

Study Officials

  • Khalil Chaibi, MD

    Medecine intensive-reanimation. Service de Réanimation médico-chirurgicale, Hôpital Avicenne, APHP, Bobigny (France)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

November 19, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

linical Data warehouse of Greater Paris University hospitals (Entrepôt de Données de Santé - EDS AP-HP ) Access

Locations