Intensive Insulin Therapy for Strict Glycemic Control in... | NCT00505505

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

NCT00505505

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Aug 7, 2008Estimated

Enrollment

800Estimated

Phase

Phase 4

Conditions

Subarachnoid Hemorrhage
Traumatic Brain Injury
Intracranial Hemorrhage

Interventions

Insulin (Actrapid)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 20, 2007

First Submission Date that Met QC Criteria

Jul 20, 2007

First Posted Date

Jul 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2008

Last Update Posted Date

Aug 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Insulin (Actrapid)	Drug	50 UI Actrapid diluted in 50 ml of saline	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Episodes of hypoglycemia

Secondary Outcomes

Measure	Description	Time Frame
Infection rate		during the study
Vasospasm rate		during the study
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subarachnoid hemorrhage
Traumatic brain injury
Intracranial hemorrhage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico Bilotta, MD, PhD	Contact	39 339 33 708 22		bilotta@tiscali.it
Vincenzo Cuzzone	Contact

Overall Officials

Name	Affiliation	Role
Federico Bilotta, MD, PhD	Department of Anesthesiology, Critical Care and Pain Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rome La Sapienza	Recruiting	Rome			Italy

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D000070642	Brain Injuries, Traumatic
D020300	Intracranial Hemorrhages
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000006	insulin, neutral

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided