Glucose Control In Hematopoetic Stem Cell Transplant

March 23, 2011 updated by: University of Oklahoma
To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18
  • Must meet standard criteria for HSCT
  • If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm

Exclusion Criteria:

  • If on intensive arm patient must stop all oral hyperglycemic meds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Regular Sliding Scale Insulin administration for hyperglycemia
Drug: Regular Insulin
Use of sliding scale insulin as per Appendix 1
Experimental: Arm 2
MiniMed Paradigm monitoring device for hyperglycemia
Device: Deployment of the MiniMed Paradigm monitoring device
Automated insulin delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Time Frame: 100 days
100 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of Infection
Time Frame: About 100 days
About 100 days
Reduced Length of In-hospital Stay
Time Frame: About 100 days
About 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Oklahoma Center for the Advancement of Science and Technology

Investigators

  • Principal Investigator: George Selby, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glucose Control
  • OCAST HR06-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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