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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
Saint Louis VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 9, 2008
Last Updated
July 14, 2009
Sponsor
Saint Louis VA Medical Center
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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

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Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure

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