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

Sponsor

Hospital Sao Domingos (Other)

Overall Status

Completed

CT.gov ID

NCT00738504

Collaborator

(none)

337

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Injury

Study Design

Study Type:

Observational

Observational Model:

Case-Control

Time Perspective:

Retrospective

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.

Study Start Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.