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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03302624
Other study ID # CHU-351
Secondary ID
Status Recruiting
Phase N/A
First received October 2, 2017
Last updated October 5, 2017
Start date September 1, 2017
Est. completion date December 31, 2017

Study information

Verified date October 2017
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 0473751195
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 506
Est. completion date December 31, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of chronic kidney disease incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary severity of CKD according to the International Classification of Chronic Kidney Disease Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary impact of the renal replacement therapy on long-term renal function 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 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary quality of life Quality of life will be assessed with the Q5D score 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary Activities of daily living Activities of daily living will be assessed with the Katz adjustment scales 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary Mortality Mortality 5 years after the first acute kidney injury requiring renal replacement therapy
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