Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Recruiting

Phase 4 Results N/A

Trial Description

The purpose of this prospective randomized controlled trial was to compare intensive insulin therapy with a carbohydrate restrictive strategy in patients with acute ischemic stroke evaluating the outcome through the Glasgow Outcome Scale Extended, hospital mortality and NIHSS during the ICU stay.

Conditions

Interventions

  • Carbohydrate restrictive strategy Other
    Intervention Desc: Patients will receive intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16.7% proteins and 50% lipids. These patients will receive 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Carbohydrate restrictive strategy
  • Intensive insulin therapy Drug
    Intervention Desc: Continuous intravenous regular insulin infusion will be adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 and 120 mg/dl. Patients will be submitted to capillary glycemic measurements every 2 hours. The insulin dose is adjusted according to an algorithm run by nurses and overseen by physicians. These patients will receive glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Intensive insulin therapy

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological outcome through the Glasgow Outcome Scale Extended At least 4 months after hospital discharge Yes
Secondary NIHSS during ICU stay ICU stay Yes
Secondary Hospital mortality Hospital stay Yes

Sponsors