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NCT00738504 Clinical Trial

Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.

Injury Clinical Trial

Official title:
INTENSIVE INSULIN THERAPY REALLY REDUCES THE INCIDENCE OF ACUTE KIDNEY INJURY IN CRITICALLY ILL PATIENTS? An Analysis Using the RIFLE Criteria for Definition of Acute Kidney Injury.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00738504
Other study ID # HSaoDomingos N 051/2008
Secondary ID
Status Completed
Phase N/A
First received August 18, 2008
Last updated August 19, 2008
Start date June 2008

Study information
Verified date August 2008
Source Hospital Sao Domingos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.

Recruitment information / eligibility
Status Completed
Enrollment 337
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission.

Exclusion Criteria:

- pregnant patients

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Hospital Sao Domingos Sao Luis MA

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the renal function outcome, defined by the RIFLE criteria in patients submitted to two different regimens of glycemic control: a carbohydrate restrictive strategy and intensive insulin therapy.
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