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Glucose Regulation in Acute Stroke Patients (GRASP) Study

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ClinicalTrials.gov Identifier: NCT00282867
Recruitment Status : Completed
First Posted : January 27, 2006
Results First Posted : August 21, 2009
Last Update Posted : August 21, 2009
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke
Hyperglycemia
Interventions Drug: IV glucose insulin and potassium, GIK
Other: standard care
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group
Hide Arm/Group Description target glucose level 70-110 mg/dL target glucose level 70 – 200 mg/dL target level 70 - 300 mg/dL
Period Title: Overall Study
Started 24 25 25
Completed 23 24 25
Not Completed 1 1 0
Reason Not Completed
d/c prior to prim outcome, 3 m f/u done             1             1             0
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group Total
Hide Arm/Group Description target glucose level 70-110 mg/dL target glucose level 70 – 200 mg/dL target level 70 - 300 mg/dL Total of all reporting groups
Overall Number of Baseline Participants 24 25 25 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 25 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  45.8%
8
  32.0%
12
  48.0%
31
  41.9%
>=65 years
13
  54.2%
17
  68.0%
13
  52.0%
43
  58.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 25 participants 74 participants
Female
11
  45.8%
12
  48.0%
10
  40.0%
33
  44.6%
Male
13
  54.2%
13
  52.0%
15
  60.0%
41
  55.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 25 participants 25 participants 74 participants
24 25 25 74
1.Primary Outcome
Title Hypoglycemic Events
Hide Description hypoglycemic events
Time Frame up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group
Hide Arm/Group Description:
target glucose level 70-110 mg/dL
target glucose level 70 – 200 mg/dL
target level 70 - 300 mg/dL
Overall Number of Participants Analyzed 23 24 25
Measure Type: Number
Unit of Measure: participants
7 1 1
2.Secondary Outcome
Title Favorable 3 Month Modified Rankin
Hide Description 3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group
Hide Arm/Group Description:
target glucose level 70-110 mg/dL
target glucose level 70 – 200 mg/dL
target level 70 - 300 mg/dL
Overall Number of Participants Analyzed 23 24 25
Measure Type: Number
Unit of Measure: percentage of participants
42 25 33
3.Other Pre-specified Outcome
Title Symptomatic Hypoglycemia
Hide Description symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period
Time Frame up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group
Hide Arm/Group Description:
target glucose level 70-110 mg/dL
target glucose level 70 – 200 mg/dL
target level 70 - 300 mg/dL
Overall Number of Participants Analyzed 23 24 25
Measure Type: Number
Unit of Measure: participants
0 1 0
4.Post-Hoc Outcome
Title Target Glucose Concentration
Hide Description glucose in target range in first 24 hours
Time Frame first 24 hours after initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol no analysis of this endpoint was performed in the "usual care" group.
Arm/Group Title Tight Control Group Loose Control Group Usual Care Group
Hide Arm/Group Description:
target glucose level 70-110 mg/dL
target glucose level 70 – 200 mg/dL
target level 70 - 300 mg/dL
Overall Number of Participants Analyzed 23 24 0
Measure Type: Number
Unit of Measure: participants
10 22
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karen C. Johnston, MD, MSc
Organization: University of Virginia
Phone: 434 924-5323
EMail: kj4v@virginia.edu
Layout table for additonal information
Responsible Party: Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology, University of Virginia
ClinicalTrials.gov Identifier: NCT00282867     History of Changes
Other Study ID Numbers: 11901
R01NS050192 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: July 14, 2009
Results First Posted: August 21, 2009
Last Update Posted: August 21, 2009