Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00747279
• Other study ID #: HSD001
• Status: Recruiting
• Phase: Phase 4
• First received: September 4, 2008
• Last updated: September 8, 2008
• Start date: June 2007

Study information

• Verified date: September 2008
• Source: Hospital Sao Domingos
• Contact: JOSE R AZEVEDO, MD
• Phone: 55 98 32275735
• Email: jrazevedo[@]elo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with acute ischemic stroke defined as: Abrupt onset of focal neurologic deficit

• No evidence of intracranial hemorrhage at non-contrasted CT scan.

Exclusion Criteria:

• Age below 18

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Other:
• Carbohydrate restrictive strategy
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.

Drug:
• Intensive insulin therapy
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.

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	Sao Luis	MA

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	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