Recruiting

Insulin Treatments

Sponsor:

University of Virginia

Code:

NCT03895138

Conditions

Coronary Artery Bypass

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard Glucommander Protocol (SGP)

Optimized Glucommander (OGM)

Study Details

Brief summary:

The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.

Conditions

Coronary Artery Bypass

Study ID

NCT03895138

Start date

Mar 19, 2018

Status verified date

Feb, 2019

Completion date

Apr 30, 2019

Anticipated

Primary completion date

Apr 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients admitted for CABG and/or open heart valve surgery
2. Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations
3. Age of 40-75, inclusive

Exclusion Criteria:

1. History of severe hypoglycemia within six months of hospital admission
2. Currently undergoing dialysis or renal replacement therapy
3. Women of childbearing potential
4. Patients with endocarditis needing valve replacement
5. Participation in another clinical trial at the time of screening.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Standard Glucommander Protocol (SGP)

CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations

experimental: Optimized Glucommander (OGM)

CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol

Interventions

Standard Glucommander Protocol (SGP)

Subjects receive standard Glucommander-based insulin therapy from the clinical staff of U.Va.'s cardiothoracic ICU and follow manufacturer's guidelines for starting with an initial multiplier value of .05.

Optimized Glucommander (OGM)

The experimental arm of the study involves treating subjects with a lower initial multiplier (.02 versus .05), a higher set of BG thresholds (140-180 mg/dl vs 120-160) in the first eight (8) hours of care for avoidance of hypoglycemia in that time period, and a requirement for consistent hourly-or-faster sampling of BG (as opposed to the Glucommander recommendation which is dependent on the trajectory of BG and can sometimes allow intervals of two hours between samples). After the eight (8) hours, the Glucommander is set back to the standard protocol for the entire duration of the subject's post-operative hospital stay.

Primary outcome measure

  • Exposure to risk of hypoglycemia [ Time Frame: 24 hours of post-operative hospital stay ]

Central Contacts and Locations

Central contacts

Anna Buhle

4349898257ab7ga@virginia.edu

leon farhi, PhD

4342966583leon@virginia.edu

Locations

University of Vrginia

Recruiting

Charlottesville, Virginia, United States, 22901

Contacts

Anna Buhle

434-989-8257ab7ga@virginia.edu

Principal Investigator:

Anthony L McCall, MD, PhD

More Information

Sponsor

University of Virginia

Last update posted

Mar 29, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-03-29.