NCT03302624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 2, 2017

Last Update Submit

October 5, 2017

Conditions

Acute Kidney InjuriesQuality of LifeChronic Kidney DiseaseRenal Replacement Therapy

Keywords

acute kidney injuryquality of lifeRenal replacement therapyIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • severity of CKD according to the International Classification of Chronic Kidney Disease

    5 years after the first acute kidney injury requiring renal replacement therapy

  • impact of the renal replacement therapy on long-term renal function

    5 years after the first acute kidney injury requiring renal replacement therapy

  • quality of life

    5 years after the first acute kidney injury requiring renal replacement therapy

  • Activities of daily living

    5 years after the first acute kidney injury requiring renal replacement therapy

  • Mortality

    5 years after the first acute kidney injury requiring renal replacement therapy

Study Arms (1)

Patients who were included in ELVIS study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

  • Pregnant or nursing woman's job

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.

    PMID: 36447221DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre LAUTRETTE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

September 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

FR(1)