Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke (INSULINFARCT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00472381
First received: May 10, 2007
Last updated: June 4, 2014
Last verified: September 2012
  Purpose

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.


Condition Intervention Phase
Acute Stroke
Acute Cerebral Ischemia
Drug: Insulin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Modified Rankin Scale at three months [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • Magnetic resonance imaging (MRI) infarct growth at one day [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Percentage of patients with hypoglycaemic event (< 3 mmol/l) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: May 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Insulin
Drug: Insulin
Insulin
Other Name: Insulin

Detailed Description:

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Carotid territory stroke
  • MRI performed in the first five hours of stroke onset
  • Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
  • Time between MRI and treatment under one hour

Exclusion Criteria:

  • Pre-existing Modified Rankin Scale of three or higher
  • Advanced or terminal illness with risk of death in the next 6 months, addiction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472381

Locations
France
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Poissy, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves Samson, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00472381     History of Changes
Other Study ID Numbers: P060202
Study First Received: May 10, 2007
Last Updated: June 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Ischemic Stroke
Post-Stroke Hyperglycaemia
Insulin treatment
Insulin
DWI
MRI

Additional relevant MeSH terms:
Cerebral Infarction
Brain Ischemia
Ischemia
Stroke
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014