Kidney Failure, AcuteEARLINCT00806039
Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure
A study testing Early Renal Involvement in people with Kidney Failure, Acute and Renal Insufficiency, Acute, run by Saint Louis VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure
- What is being tested?
- Early Renal Involvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2009
- Phase
- Interventional
- 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
Who may be able to join
- Hospitalized, elevation in creatinine meeting definition
Who cannot join
- CDK5, ESRD,solid organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis VA Medical Center
St Louis, Missouri, 63106
About this study
Official title: Impact of EArly Renal Involvement on the Developement of Severe In-hospital Renal Failure
The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.
- Being tested
- Early Renal Involvement
- Keywords
- Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Renal InvolvementOther
Renal Consultation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Early renal involvement Receives: Other: Early Renal Involvement |
| 2 | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe renal Failure
Measured: 10 days
Secondary outcomes (1)
Composite outcome morbidity mortality
Measured: hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Louis VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Tarek M El-Achkar, MD, Study director, Saint Louis VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806039
- Sponsor's protocol ID
- 1143004
- Acronym
- EARLI
- Status last verified
- Jul 2009
- First submitted
- 9 Dec 2008
- Last updated
- 16 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Balasubramanian G, Al-Aly Z, Moiz A, Rauchman M, Zhang Z, Gopalakrishnan R, Balasubramanian S, El-Achkar TM. Early nephrologist involvement in hospital-acquired acute kidney injury: a pilot study. Am J Kidney Dis. 2011 Feb;57(2):228-34. doi: 10.1053/j.ajkd.2010.08.026. Epub 2010 Dec 31.
PubMed 21195518
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of EArly Renal Involvement on the Developement of Severe In-hospital Renal Failure
- ClinicalTrials.gov ID
- NCT00806039
- Acronym / sponsor ID
- EARLI / 1143004
- Keywords
- Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Saint Louis VA Medical CenterUS federal agency
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 10 Dec 2008 (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.
The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Early Renal InvolvementEarly renal involvement |
| 2 | No intervention | –control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized, elevation in creatinine meeting definition
Key exclusion criteria (1 listed)
- CDK5, ESRD,solid organ transplant
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 |
|---|---|---|
| Early Renal InvolvementRenal Consultation | Other | 1 |
Primary outcome
Severe renal Failure
Time frame: 10 days
1 secondary outcome
Composite outcome morbidity mortality
Time frame: hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2009.
- Derived from this study: PubMed 21195518Balasubramanian G, Al-Aly Z, Moiz A, Rauchman M, Zhang Z, Gopalakrishnan R, Balasubramanian S, El-Achkar TM. Early nephrologist involvement in hospital-acquired acute kidney injury: a pilot study. Am J Kidney Dis. 2011 Feb;57(2):228-34. doi: 10.1053/j.ajkd.2010.08.026. Epub 2010 Dec 31.
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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.
Tarek M El-Achkar, MD study director
Saint Louis VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Renal Involvement in people with Kidney Failure, Acute and Renal Insufficiency, Acute, run by Saint Louis VA Medical Center at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2009. 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 United States. 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?
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?
Severe renal Failure (time frame: 10 days). 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 NCT00806039, 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 16 Jul 2009.