Normoglycemia and Neurological Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137773
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 4, 2010
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions: Acute, Non-traumatic Subarachnoid Hemorrhage
Intraparenchymal Hemorrhage
Brain Injuries
Interventions: Drug: Insulin
Drug: Conventional insulin treatment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Intensive IV Insulin Patients received target glucose levels of 80-110 mg/dl
Conventional Insulin Treatment Subjects received conventional (150–170 mg/dl) glucose control

Participant Flow:   Overall Study
    Intensive IV Insulin   Conventional Insulin Treatment
STARTED   33   23 
COMPLETED   24   20 
Death                3                3 
Lost to Follow-up                6                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Intensive IV Insulin Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl
Convention Insulin Treatment conventional (150–170 mg/dl, n = 20) glucose control
Total Total of all reporting groups

Baseline Measures
   Intensive IV Insulin   Convention Insulin Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   23   56 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33 100.0%      23 100.0%      56 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      23  69.7%      13  56.5%      36  64.3% 
Male      10  30.3%      10  43.5%      20  35.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
United States   33   23   56 

  Outcome Measures

1.  Primary:   Karnovsky Performance Status Scale of Functional Impairment   [ Time Frame: 3 months ]

2.  Secondary:   Blood Glucose Concentration   [ Time Frame: 24 h ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Rainer Lenhardt, MD
Organization: University Louisville
phone: 502-228-7517

Responsible Party: Rainer Lenhardt, University of Louisville Identifier: NCT01137773     History of Changes
Other Study ID Numbers: UofL IRB #562.06
First Submitted: June 3, 2010
First Posted: June 4, 2010
Results First Submitted: April 9, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017