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

August 19, 2008 updated by: Hospital Sao Domingos

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- MA
  - Sao Luis, MA, Brazil, 65000
    - Hospital Sao Domingos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We are going to evaluate retrospectively the occurrence of acute kidney injury defined by the RIFLE criteria in a population of patients submitted to two different strategies for glycemic control: a carbohydrate restrictive strategy or intensive insulin therapy. The protocol of the original trial that we are going to summarize below, was approved by the Research Ethical Committee of the Federal University of Maranhão. 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1
2
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Domingos

Investigators

Principal Investigator: JOSE R AZEVEDO, MD, Director. BRAZILIAN ASSOCIATION OF INTENSIVE CARE MEDICINE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)