Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure (EARLI)
Primary Purpose
Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Renal Involvement
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure, Acute focused on measuring Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Hospitalized, elevation in creatinine meeting definition
Exclusion Criteria:
- CDK5, ESRD,solid organ transplant
Sites / Locations
- Saint Louis VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
1
2
Arm Description
Early renal involvement
control
Outcomes
Primary Outcome Measures
Severe renal Failure
Secondary Outcome Measures
Composite outcome morbidity mortality
Full Information
NCT ID
NCT00806039
First Posted
December 9, 2008
Last Updated
July 14, 2009
Sponsor
Saint Louis VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00806039
Brief Title
Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure
Acronym
EARLI
Official Title
Impact of EArly Renal Involvement on the Developement of Severe In-hospital Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Saint Louis VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
Keywords
Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Early renal involvement
Arm Title
2
Arm Type
No Intervention
Arm Description
control
Intervention Type
Other
Intervention Name(s)
Early Renal Involvement
Intervention Description
Renal Consultation
Primary Outcome Measure Information:
Title
Severe renal Failure
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Composite outcome morbidity mortality
Time Frame
hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized, elevation in creatinine meeting definition
Exclusion Criteria:
CDK5, ESRD,solid organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek M El-Achkar, MD
Organizational Affiliation
Saint Louis VA Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Saint Louis VA Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21195518
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure
We'll reach out to this number within 24 hrs