Kidney Failure, AcuteNCT00316576
Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA)
An observational study of Kidney Failure, Acute and Critical Illness, run by University Hospital, Caen at 1 site in France.
Trial summary
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute, Critical Illness
- What is being tested?
- Blood sampling for PCR
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Nov 2006
- 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: Consecutive patients admitted to ICU fore more than 48 hours
Who may be able to join
- Age > 18 yrs
- ICU stay > 48 hours
Who cannot join
- Age < 18 yrs
- Creatinine > 180 µmol/L
- Absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on the Development of Acute Renal Failure in Critically Ill Patients
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.
Read the detailed description
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.
- Conditions
- Kidney Failure, Acute, Critical Illness
- Being tested
- Blood sampling for PCR
- Keywords
- Kidney failure, Acute, Genetic Polymorphism, Angiotensin-converting enzyme
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for PCRProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ARF
Measured: During ICU stay
Secondary outcomes (1)
Mortality
Measured: ICU and Hospital mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startMay 2006
- Study completionNov 2006
Why it stopped: The study was stopped on november 2006 after inclusion was fulfilled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Damien du Cheyron, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316576
- Sponsor's protocol ID
- 05-130
- Status last verified
- Jan 2008
- First submitted
- 19 Apr 2006
- Last updated
- 17 Jan 2008
- Results posted
- No
Publications
du Cheyron D, Fradin S, Ramakers M, Terzi N, Guillotin D, Bouchet B, Daubin C, Charbonneau P. Angiotensin converting enzyme insertion/deletion genetic polymorphism: its impact on renal function in critically ill patients. Crit Care Med. 2008 Dec;36(12):3178-83. doi: 10.1097/CCM.0b013e318186a299.
PubMed 19020433
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on the Development of Acute Renal Failure in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00316576
- Acronym / sponsor ID
- 05-130
- Conditions
- Kidney Failure, Acute, Critical Illness
- Keywords
- Kidney failure, Acute, Genetic Polymorphism, Angiotensin-converting enzyme
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped on november 2006 after inclusion was fulfilled
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Apr 2006 (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.
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.
Detailed description
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to ICU fore more than 48 hours
Key inclusion criteria (2 listed)
- Age > 18 yrs
- ICU stay > 48 hours
Key exclusion criteria (3 listed)
- Age < 18 yrs
- Creatinine > 180 µmol/L
- Absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for PCR | Procedure or surgery | – |
Primary outcome
Incidence of ARF
Time frame: During ICU stay
1 secondary outcome
Mortality
Time frame: ICU and Hospital mortality
Results and safety
The study was stopped early (reason given: The study was stopped on november 2006 after inclusion was fulfilled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
- Derived from this study: PubMed 19020433du Cheyron D, Fradin S, Ramakers M, Terzi N, Guillotin D, Bouchet B, Daubin C, Charbonneau P. Angiotensin converting enzyme insertion/deletion genetic polymorphism: its impact on renal function in critically ill patients. Crit Care Med. 2008 Dec;36(12):3178-83. doi: 10.1097/CCM.0b013e318186a299.
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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.
Damien du Cheyron, MD principal investigator
University Hospital, Caen
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 Kidney Failure, Acute and Critical Illness, run by University Hospital, Caen 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 3 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: stopped early, as of the sponsor's last update on 17 Jan 2008. 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 was stopped early (reason given: The study was stopped on november 2006 after inclusion was fulfilled). Results are not available in the source record.
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?
Incidence of ARF (time frame: During ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316576, which also lists 1 linked publication.
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 17 Jan 2008.