Impact of Early Renal Involvement on the Development of S... | NCT00806039

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

NCT00806039

Sponsor

Saint Louis VA Medical Center

Status

Unknown status

Last Update Posted

Jul 16, 2009Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Kidney Failure, Acute
Renal Insufficiency, Acute
Kidney Failure
Renal Insufficiency

Interventions

Early Renal Involvement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Dec 9, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2009

Last Update Posted Date

Jul 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Early renal involvement	Other: Early Renal Involvement
2	No Intervention	control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early Renal Involvement	Other	Renal Consultation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severe renal Failure		10 days

Secondary Outcomes

Measure	Description	Time Frame
Composite outcome morbidity mortality		hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized, elevation in creatinine meeting definition

Exclusion Criteria:

CDK5, ESRD,solid organ transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarek M El-Achkar, MD	Saint Louis VA Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Louis VA Medical Center		St Louis	Missouri	63106	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21195518	Derived	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.

ID	Term
D058186	Acute Kidney Injury
D051437	Renal Insufficiency

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications