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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
Enrollment 56

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive IV Insulin Conventional Insulin Treatment
Hide Arm/Group Description Patients received target glucose levels of 80-110 mg/dl Subjects received conventional (150–170 mg/dl) glucose control
Period Title: Overall Study
Started 33 23
Completed 24 20
Not Completed 9 3
Reason Not Completed
Death             3             3
Lost to Follow-up             6             0
Arm/Group Title Intensive IV Insulin Convention Insulin Treatment Total
Hide Arm/Group Description Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl conventional (150–170 mg/dl, n = 20) glucose control Total of all reporting groups
Overall Number of Baseline Participants 33 23 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 23 participants 56 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 23 participants 56 participants
Female
23
  69.7%
13
  56.5%
36
  64.3%
Male
10
  30.3%
10
  43.5%
20
  35.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants 23 participants 56 participants
33
 100.0%
23
 100.0%
56
 100.0%
1.Primary Outcome
Title Karnovsky Performance Status Scale of Functional Impairment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive IV Insulin Convention Insulin Treatment
Hide Arm/Group Description:
Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
conventional (150–170 mg/dl, n = 20) glucose control
Overall Number of Participants Analyzed 24 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
53  (55) 60  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive IV Insulin, Convention Insulin Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Blood Glucose Concentration
Hide Description average blood glucose concentration while the patients received insulin drip
Time Frame 24 h
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive IV Insulin Conventional Insulin Treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 24 20
Mean (Standard Deviation)
Unit of Measure: mg/dl blood
99  (9) 138  (20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive IV Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .70
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive IV Insulin Convention Insulin Treatment
Hide Arm/Group Description Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl target glucose levels of 150-170 mg/dl
All-Cause Mortality
Intensive IV Insulin Convention Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   3/33 (9.09%)   3/23 (13.04%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive IV Insulin Convention Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive IV Insulin Convention Insulin Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/23 (0.00%) 
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
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