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

A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Chronic Kidney Disease; Renal Replacement Therapy; Acute Kidney Injuries

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 Type: Observational
• Enrollment (Anticipated): 506

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Chu Clermont-Ferrand
    • Sub-Investigator: Jean-Michel CONSTANTIN
    • Principal Investigator: Alexandre LAUTRETTE
    • Sub-Investigator: Carole SCHWEBEL
    • Sub-Investigator: Didier GRUSON
    • Sub-Investigator: Elie AZOULAY
    • Sub-Investigator: Kada KLOUCHE
    • Sub-Investigator: Laurent ARGAUD
    • Sub-Investigator: Julien BOHE
    • Sub-Investigator: Cédric Bruel
    • Sub-Investigator: Christophe MARIAT
    • Sub-Investigator: Yves COHEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who were included in ELVIS study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Mortality	Mortality	5 years after the first acute kidney injury requiring renal replacement therapy

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Alexandre Lautrette, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; acute kidney injury; Intensive care unit; Renal replacement therapy
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CHU-351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No