Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

NCT00747279 | Unknown Phase 4

• 1 other identifier: HSD001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Neurological outcome through the Glasgow Outcome Scale Extended

  At least 4 months after hospital discharge

Secondary Outcomes (2)

• NIHSS during ICU stay

  ICU stay

• Hospital mortality

  Hospital stay

Study Arms (2)

1

EXPERIMENTAL

Carbohydrate restrictive strategy

Other: Carbohydrate restrictive strategy

2

ACTIVE COMPARATOR

Intensive insulin therapy

Drug: Intensive insulin therapy

Interventions

Carbohydrate restrictive strategy OTHER

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.

1

Intensive insulin therapy DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with acute ischemic stroke defined as: Abrupt onset of focal neurologic deficit
• No evidence of intracranial hemorrhage at non-contrasted CT scan.

You may not qualify if:

• Age below 18
• Pregnancy

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

JOSE R AZEVEDO, MD

CONTACT

55 98 32275735; jrazevedo@elo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: June 1, 2007
• Last Updated: September 9, 2008

Record last verified: 2008-09

Locations

BR (1)