IRA Cible: Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT03192189

Collaborator

(none)

319

Enrollment

Location

21.4

Actual Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Acute Kidney Injury	Other: monitoring for progression to chronic kidney disease

Study Design

Study Type:

Observational

Actual Enrollment :

319 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations

Actual Study Start Date :

Aug 20, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients with acute kidney injury Requiring treatment with dialysis	Other: monitoring for progression to chronic kidney disease Collect clinical information and assess risk factors

Arm

Intervention/Treatment

Patients with acute kidney injury

Requiring treatment with dialysis

Other: monitoring for progression to chronic kidney disease

Collect clinical information and assess risk factors

Outcome Measures

Primary Outcome Measures

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 [6 months]

Secondary Outcome Measures

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 [6 months]
Identify renal phenotype of patients with chronic kidney disease [6 months]
characterization from renal biopsy
Evaluate mortality during hospital stay [1 months]
Evaluate mortality at medium-term [6 months]
Identify specific therapeutic interventions put into place during the 6 month consultation [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nimes	Nîmes		France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT03192189

Other Study ID Numbers:

LOCAL/2016/OM-01

First Posted:

Jun 20, 2017

Last Update Posted:

Nov 10, 2021

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Acute Kidney Injury

Wounds and Injuries

Study Results

No Results Posted as of Nov 10, 2021