- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03192189
Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations (IRA Cible)
November 14, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease.
Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization.
Risk factors of developing chronic kidney disease between hospital visits are understudied.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
319
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- CHU Nimes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing dialysis for acute kidney injury.
All new adults (>18 years old) hospitalized in a university center with severe AKI was included from August 2016 to December 2017.
Inclusion criteria was a severe AKI defined by dialysis start for AKI or an increase of Scr upper 354 μmol/L.
Exclusion criteria was CKD stage 5 , patients living with kidney transplant, plan dialysis for bilateral surgery nephrectomy, patient witch justice protection and refuse to participate.
Eligible patients were identified by physicians for ICU and nephrology department and by laboratory biochemistry department for others wards.
A Biochemistry alert system controlled the exhaustively of inclusion in ICU and Nephrology department during the period of the study.
Description
Inclusion Criteria:
- Age >18 years
- Suffering from acute kidney injury treated with dialysis
- hospitalized in a university center from August 2016 to December 2017 with severe AKI defined according to 2 of the 3 criterion definitions of KDIGO stage AKI: an increase in SCr above 354 μmol/Lor renal replacement therapy (RRT) indication, but not the 3-fold increase in SCr increase within 7 days with SCr below 354 μmol/L.
- The patient has been informed and does not oppose the study
- The patient is insured or the beneficiary of a health insurance policy
Exclusion Criteria:
- The patients is under judicial protection or state guardianship
- Patient has chronic kidney disease(CKD) KDIGO stage 5
- It proves impossible to give the patient clear information
- patients living with kidney transplant
- plan dialysis for bilateral surgery nephrectomy
- patient refuse to participate and patients with no health insurance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with acute kidney injury
Requiring treatment with dialysis
|
Collect clinical information and assess risk factors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Develop a prognostic score of progression to chronic kidney disease at 6 months in patients requiring hospitalization for dialysis for acute kidney injury to identify those who would benefit from consultation with a nephrologist
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify new risk factors for progression to chronic kidney disease at 6 months post dialysis for acute kidney injury pre-hospitalization and during hospitalization and day of discharge
Time Frame: 6 months
|
6 months
|
|
|
Identify renal phenotype of patients with chronic kidney disease
Time Frame: 6 months
|
characterization from renal biopsy
|
6 months
|
|
Evaluate mortality during hospital stay
Time Frame: 1 months
|
1 months
|
|
|
Evaluate mortality at medium-term
Time Frame: 6 months
|
6 months
|
|
|
Identify specific therapeutic interventions put into place during the 6 month consultation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2016
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
June 16, 2017
First Submitted That Met QC Criteria
June 16, 2017
First Posted (Actual)
June 20, 2017
Study Record Updates
Last Update Posted (Estimated)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Acute Kidney Injury
- Renal Insufficiency, Chronic
Other Study ID Numbers
- LOCAL/2016/OM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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