Critical IllnessPROVEERNCT02897310
Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy
An observational study of Critical Illness and Acute Kidney Injury, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury
- How many people
- 245 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults hospitalised in intensive care and who developped acute renal failure requiring renal replacement therapy
Who may be able to join
- Adults admitted to the intensive care
- Acute kidney failure requiring renal replacement therapy
Who cannot join
- Patients suffering end stage renal failure requiring chronic renal replacement therapy
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- critically ill patients, acute kidney injury, renal replacement therapy, long term outcome
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients | critically ill patients with acute kidney failure requiring renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year mortality
vital status
Measured: year 1
Secondary outcomes (2)
hospital mortality
Measured: year 1
one year renal function
Measured: Year one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aubron Cécile, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897310
- Sponsor's protocol ID
- PROVEER
- Acronym
- PROVEER
- Status last verified
- Sep 2016
- First submitted
- 19 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02897310
- Acronym / sponsor ID
- PROVEER / PROVEER
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- critically ill patients, acute kidney injury, renal replacement therapy, long term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | –critically ill patients with acute kidney failure requiring renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults hospitalised in intensive care and who developped acute renal failure requiring renal replacement therapy
Key inclusion criteria (2 listed)
- Adults admitted to the intensive care
- Acute kidney failure requiring renal replacement therapy
Key exclusion criteria (2 listed)
- Patients suffering end stage renal failure requiring chronic renal replacement therapy
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
one-year mortality
Time frame: year 1
vital status
2 secondary outcomes
hospital mortality
Time frame: year 1
one year renal function
Time frame: Year one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aubron Cécile study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Acute Kidney Injury, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year mortality (time frame: year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.