SURIA: Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Unknown status
CT.gov ID
NCT03302624
Collaborator
(none)
506
1
4
127.3

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

Detailed Description

Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.

Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.

Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.

Study Design

Study Type:
Observational
Anticipated Enrollment :
506 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Patients who were included in ELVIS study

Outcome Measures

Primary Outcome Measures

  1. incidence of chronic kidney disease [5 years after the first acute kidney injury requiring renal replacement therapy]

    incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy

Secondary Outcome Measures

  1. severity of CKD according to the International Classification of Chronic Kidney Disease [5 years after the first acute kidney injury requiring renal replacement therapy]

    Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation

  2. impact of the renal replacement therapy on long-term renal function [5 years after the first acute kidney injury requiring renal replacement therapy]

    Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis

  3. quality of life [5 years after the first acute kidney injury requiring renal replacement therapy]

    Quality of life will be assessed with the Q5D score

  4. Activities of daily living [5 years after the first acute kidney injury requiring renal replacement therapy]

    Activities of daily living will be assessed with the Katz adjustment scales

  5. Mortality [5 years after the first acute kidney injury requiring renal replacement therapy]

    Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h

Exclusion Criteria:

Pregnant or nursing woman's job

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Alexandre LAUTRETTE, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT03302624
Other Study ID Numbers:
  • CHU-351
First Posted:
Oct 5, 2017
Last Update Posted:
Oct 6, 2017
Last Verified:
Oct 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2017