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Glucose Control In Hematopoetic Stem Cell Transplant

This study has been terminated.
(study terminated due to lack of enrollment)
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00582036
First received: December 19, 2007
Last updated: March 23, 2011
Last verified: March 2011
Results First Received: January 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hyperglycemia
Hematopoietic Stem Cell Transplantation
Interventions: Drug: Regular Insulin
Device: Deployment of the MiniMed Paradigm monitoring device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was not satisfactory to study completion; study terminated early.

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
Arm 1 Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
Arm 2

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     5     6  
COMPLETED     5     5 [1]
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  
[1] One patient withdrew consent



  Baseline Characteristics
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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
Arm 1 Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
Arm 2

Baseline IV Insulin infusion begins with:

>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime

Sliding Scale IV Insulin adjustments based on:

>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  5     6     11  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     6     11  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  60  ± 1     58  ± 2     59  ± 2  
Gender  
[units: participants]
     
Female     3     1     4  
Male     2     5     7  
Region of Enrollment  
[units: participants]
     
United States     5     6     11  



  Outcome Measures

1.  Primary:   Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)   [ Time Frame: 100 days ]

2.  Secondary:   Reduction of Infection   [ Time Frame: About 100 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Reduced Length of In-hospital Stay   [ Time Frame: About 100 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This study was terminated early due to lack of enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: George Selby, MD
Organization: University of Oklahoma Health Sciences Center
phone: 405-271-4022
e-mail: george-selby@ouhsc.edu


No publications provided


Responsible Party: Goerge Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582036     History of Changes
Other Study ID Numbers: Glucose Control, OCAST HR06-13
Study First Received: December 19, 2007
Results First Received: January 6, 2011
Last Updated: March 23, 2011
Health Authority: United States: Institutional Review Board