NCT00505505

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
Last Updated

August 7, 2008

Status Verified

July 1, 2007

First QC Date

July 20, 2007

Last Update Submit

August 6, 2008

Conditions

Subarachnoid HemorrhageTraumatic Brain InjuryIntracranial Hemorrhage

Keywords

Neurointensive careIntensive insulin infusionHypoglycemiaPostoperative MortalityPostoperative MorbidityNeurologic outcome

Outcome Measures

Primary Outcomes (1)

  • Episodes of hypoglycemia

Secondary Outcomes (4)

  • Infection rate

    during the study

  • Vasospasm rate

    during the study

  • Mortality

    6 months follow up

  • Neurologic status

    6 months follow up

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Insulin (Actrapid)

B

ACTIVE COMPARATOR

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

Drug: Insulin (Actrapid)

Interventions

Insulin (Actrapid)DRUG

50 UI Actrapid diluted in 50 ml of saline

AB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subarachnoid hemorrhage
  • Traumatic brain injury
  • Intracranial hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome La Sapienza

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Subarachnoid HemorrhageBrain Injuries, TraumaticIntracranial HemorrhagesHypoglycemia

Interventions

insulin, neutral

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Federico Bilotta, MD, PhD

    Department of Anesthesiology, Critical Care and Pain Medicine

    STUDY CHAIR

Central Study Contacts

Federico Bilotta, MD, PhD

CONTACT

39 339 33 708 22bilotta@tiscali.it

Vincenzo Cuzzone

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

January 1, 2002

Last Updated

August 7, 2008

Record last verified: 2007-07

Locations

IT(1)