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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 ]

Measure Type Primary
Measure Title Karnovsky Performance Status Scale of Functional Impairment
Measure Description

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions:

Normal no complaints; no evidence of disease - 100 Able to carry on normal activity; minor signs or symptoms of disease- 90 Normal activity with effort; some signs or symptoms of disease - 80 Cares for self; unable to carry on normal activity or to do active work - 70 Requires occasional assistance, but is able to care for most of his personal needs - 60 Requires considerable assistance and frequent medical care - 50 Disabled; requires special care and assistance - 40 Severely disabled; hospital admission is indicated although death not imminent - 30 Very sick; hospital admission necessary; active s

Time Frame 3 months  

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 receive IV insulin to maintain target glucose levels of 80-110 mg/dl
Convention Insulin Treatment conventional (150–170 mg/dl, n = 20) glucose control

Measured Values
   Intensive IV Insulin   Convention Insulin Treatment 
Participants Analyzed   24   20 
Karnovsky Performance Status Scale of Functional Impairment 
[Units: Units on a scale]
Mean (Standard Deviation)
 53  (55)   60  (25) 


Statistical Analysis 1 for Karnovsky Performance Status Scale of Functional Impairment
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] t-test, 2 sided
P Value [4] 0.49
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Blood Glucose Concentration
Measure Description average blood glucose concentration while the patients received insulin drip
Time Frame 24 h  

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 receive IV insulin to maintain target glucose levels of 80-110 mg/dl

Insulin: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.

Conventional Insulin Treatment

Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl

Conventional insulin treatment: All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.


Measured Values
   Intensive IV Insulin   Conventional Insulin Treatment 
Participants Analyzed   24   20 
Blood Glucose Concentration 
[Units: Mg/dl blood]
Mean (Standard Deviation)
 99  (9)   138  (20) 


Statistical Analysis 1 for Blood Glucose Concentration
Groups [1] Intensive IV Insulin
Statistical Test Type [2] Superiority
Statistical Method [3] t-test, 2 sided
P Value [4] .70
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  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
No text entered.


  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