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Development of a Decision-making Aid for Referring Kidney Injury Patients in Need of Dialysis for Nephrology Consultations (IRA Cible)

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ClinicalTrials.gov Identifier: NCT03192189
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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
Chronic Kidney Diseases Acute Kidney Injury Other: monitoring for progression to chronic kidney disease

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Study Type : Observational
Actual Enrollment : 319 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Decision-making Aid for Referring Kidney Injury Patients in Need of Dialysis for Nephrology Consultations
Actual Study Start Date : August 20, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Identify renal phenotype of patients with chronic kidney disease [ Time Frame: 6 months ]
    characterization from renal biopsy

  3. Evaluate mortality during hospital stay [ Time Frame: 1 months ]
  4. Evaluate mortality at medium-term [ Time Frame: 6 months ]
  5. Identify specific therapeutic interventions put into place during the 6 month consultation [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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 by dialysis start for AKI or an increase of Scr upper 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 stage V acute kidney injury (CKD 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192189


Locations
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France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03192189     History of Changes
Other Study ID Numbers: LOCAL/2016/OM-01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency