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Normoglycemia and Neurological Outcome

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ClinicalTrials.gov Identifier: NCT01137773
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 4, 2010
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 
NOT COMPLETED   9   3 
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.
No text entered.

Reporting Groups
  Description
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 
Age 
[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


  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
e-mail: rainer.lenhardt@louisville.edu



Responsible Party: Rainer Lenhardt, University of Louisville
ClinicalTrials.gov 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