Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.
|ClinicalTrials.gov Identifier: NCT00738504|
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 20, 2008
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||337 participants|
|Observational Model:||Case Control|
|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 :||June 2008|
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 (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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738504
|Hospital Sao Domingos|
|Sao Luis, MA, Brazil, 65000|
|Principal Investigator:||JOSE R AZEVEDO, MD||Director. BRAZILIAN ASSOCIATION OF INTENSIVE CARE MEDICINE|