NCT00795015

Brief Summary

The investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

8 months

First QC Date

November 20, 2008

Last Update Submit

March 15, 2011

Conditions

Diabetes

Keywords

postoperative blood glucose controlIV insulin infusion

Outcome Measures

Primary Outcomes (1)

  • Percent of blood glucose values in the target range 80-120 mg/dl

    first 200 hours post-op in the ICU

Secondary Outcomes (1)

  • Percent of patient days with a low blood glucose, defines as less than 60 mg/dl

    200 hours while in ICU

Study Arms (2)

leuven

ACTIVE COMPARATOR

these patients had their IV insulin controlled by using the protocol adapted from van den Berghe et al. University of Leuven, Belgium, NEJM Nov. 2001

Drug: insulin regular IV infusionDrug: IV insulin infusion

glucommander

ACTIVE COMPARATOR

these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005

Drug: insulin regular IV infusionDrug: IV insulin infusion

Interventions

insulin regular IV infusionDRUG

IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared

glucommanderleuven
IV insulin infusionDRUG

IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared

glucommanderleuven

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • s/p open heart or kidney or liver transplant surgery

You may not qualify if:

  • admission blood glucose less than 120 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Baldwin, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

April 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

US(1)