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

Acute Kidney Injury Clinical Trial

— IRA Cible  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192189
• Other study ID #: LOCAL/2016/OM-01
• Status: Completed
• Start date: August 20, 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Wounds and Injuries

Intervention

Other:
• monitoring for progression to chronic kidney disease
Collect clinical information and assess risk factors

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Identify renal phenotype of patients with chronic kidney disease	characterization from renal biopsy	6 months
Secondary	Evaluate mortality during hospital stay		1 months
Secondary	Evaluate mortality at medium-term		6 months
Secondary	Identify specific therapeutic interventions put into place during the 6 month consultation		6 months