- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02897310
Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy (PROVEER)
September 7, 2016 updated by: University Hospital, Brest
This study assess the vital status, renal function and renal recovery of patients admitted to intensive care unit and requiring renal replacement therapy for acute kidney failure.
Patient follow up is up to 3 years after ICU admission when possible.
Study Overview
Status
Completed
Conditions
Detailed Description
Up to 50% of critically ill patients develop acute kidney injury and up to 10% require renal replacement therapy in the intensive care unit.
This study aims to identify factors associated with mortality and to evaluate renal recovery of patients who had acute kidney failure requiring renal replacement therapy in intensive care unit at 1 and 3 years post intensive care unit admission.
Study Type
Observational
Enrollment (Actual)
245
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29609
- CHRU de Brest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults hospitalised in intensive care and who developped acute renal failure requiring renal replacement therapy
Description
Inclusion Criteria:
- Adults admitted to the intensive care
- Acute kidney failure requiring renal replacement therapy
Exclusion Criteria:
- Patients suffering end stage renal failure requiring chronic renal replacement therapy
- Patients under 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
critically ill patients
critically ill patients with acute kidney failure requiring renal replacement therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
one-year mortality
Time Frame: year 1
|
vital status
|
year 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hospital mortality
Time Frame: year 1
|
year 1
|
one year renal function
Time Frame: Year one
|
Year one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aubron Cécile, CHRU de Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
August 19, 2016
First Submitted That Met QC Criteria
September 7, 2016
First Posted (Estimate)
September 13, 2016
Study Record Updates
Last Update Posted (Estimate)
September 13, 2016
Last Update Submitted That Met QC Criteria
September 7, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROVEER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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