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

NCT03192189 | Completed

• 1 other identifier: LOCAL/2016/OM-01
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

Study Arms (1)

Patients with acute kidney injury

Requiring treatment with dialysis

Other: monitoring for progression to chronic kidney disease

Interventions

monitoring for progression to chronic kidney disease OTHER

Collect clinical information and assess risk factors

Patients with acute kidney injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Cardinale A, Messikh Z, Antoine V, Aglae C, Reboul P, Cariou S, Muller L, Lefrant JY, Moranne O. Specificity of severe AKI aetiology and care in the elderly. The IRACIBLE prospective cohort study. J Nephrol. 2022 Nov;35(8):2097-2108. doi: 10.1007/s40620-022-01322-z. Epub 2022 May 3.

  PMID: 35503200 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: August 20, 2016
• Primary Completion: December 31, 2017
• Study Completion: June 15, 2018
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)