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| Sponsored by: |
Hospital Sao Domingos |
| Information provided by: | Hospital Sao Domingos |
| ClinicalTrials.gov Identifier: | NCT00738504 |
Purpose
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 |
|
Kidney Injury |
| ChemIDplus related topics: | Insulin |
| Study Type: | Observational |
| Study Design: | Case Control, 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. |
| Estimated Enrollment: | 337 |
| Study Start Date: | June 2008 |
| Groups/Cohorts |
| 1 |
| 2 |
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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.
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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).
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, MA | |||||
| Hospital Sao Domingos | |||||
| SAO LUIS, MA, Brazil, 65000 | |||||
| Hospital Sao Domingos |
| Principal Investigator: | JOSE R AZEVEDO, MD | Director. BRAZILIAN ASSOCIATION OF INTENSIVE CARE MEDICINE |
More Information
| Responsible Party: | HOSPITAL SAO DOMINGOS ( JOSÉ RAIMUNDO ARAUJO DE AZEVEDO ) |
| Study ID Numbers: | HSaoDomingos N 051/2008 |
| First Received: | August 18, 2008 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00738504 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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