Glucose Control In Hematopoetic Stem Cell Transplant

Hyperglycemia Clinical Trial

Official title:

Glucose Control In Hematopoetic Stem Cell Transplant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00582036
• Other study ID #: Glucose Control
• Secondary ID: OCAST HR06-13
• Status: Terminated
• Phase: N/A
• First received: December 19, 2007
• Last updated: March 23, 2011
• Start date: February 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2011
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Hyperglycemia

Intervention

Drug:
• Regular Insulin
Use of sliding scale insulin as per Appendix 1

Device:
• Deployment of the MiniMed Paradigm monitoring device
Automated insulin delivery system

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Oklahoma Center for the Advancement of Science and Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)		100 days	Yes
Secondary	Reduction of Infection		About 100 days	No
Secondary	Reduced Length of In-hospital Stay		About 100 days	No