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

NCT ID: NCT00738504

Last Updated: 2008-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Injury

Keywords

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Intensive insulin therapy Carbohydrate restrictive strategy RIFLE Criteria Acute Kidney Injury Critically ill patients Acute

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

Group 1

Group 1 (Carbohydrate Restrictive Strategy). Patients received intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16,7% proteins and 50% lipids (Glucerna, Abbott Laboratories). These patients received regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and, in stable patients, ideally below 150 mg/dl.

No interventions assigned to this group

Group 2

Group 2 (Intensive Insulin Therapy). Continuous intravenous insulin infusion was adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 to 120 mg/dl. Patients were submitted to capillary glycemic measurements every 2 hours. The insulin dose was adjusted according to an algorithm run by nurses and overseen by physicians. These patients received glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids (Diason, Nutricia Clinical Care Ltd).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Domingos

OTHER

Sponsor Role lead

Responsible Party

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HOSPITAL SAO DOMINGOS

Principal Investigators

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JOSE R AZEVEDO, MD

Role: PRINCIPAL_INVESTIGATOR

Director. BRAZILIAN ASSOCIATION OF INTENSIVE CARE MEDICINE

Locations

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Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HSaoDomingos N 051/2008

Identifier Type: -

Identifier Source: org_study_id