Skip to content

Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747279
Enrollment
70
Registered
2008-09-05
Start date
2007-06-30
Completion date
Unknown
Last updated
2008-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

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.

Interventions

OTHERCarbohydrate 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.

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.

Sponsors

Hospital Sao Domingos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Neurological outcome through the Glasgow Outcome Scale ExtendedAt least 4 months after hospital discharge

Secondary

MeasureTime frame
NIHSS during ICU stayICU stay
Hospital mortalityHospital stay

Countries

Brazil

Contacts

Primary ContactJOSE R AZEVEDO, MD
jrazevedo@elo.com.br55 98 32275735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026