Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury; Intracranial Hemorrhage

Treatments: Drug: Insulin (Actrapid)

Study type: Interventional

Funder types: Other

Identifiers

NCT00505505

1781964

Details and patient eligibility

About

Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.

Full description

Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subarachnoid hemorrhage
• Traumatic brain injury
• Intracranial hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

A

Experimental group

Description:

Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl

Treatment:

Drug: Insulin (Actrapid)

B

Active Comparator group

Description:

Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl

Treatment:

Drug: Insulin (Actrapid)