Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Tight glycemia control, cardiac surgery patients
Eligibility Criteria
Inclusion Criteria:
- patients admitted to the postoperative ICU after elective cardiac surgery
Exclusion Criteria:
- insulin allergy
Sites / Locations
- University Hospital in Prague
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Matias protocol
Bath protocol
eMPC
Arm Description
A protocol based on the absolute glucose value - Matias protocol (Matias)
A protocol based on the relative glucose change - Bath protocol (Bath)
a computer-based model predictive control algorithm with variable sampling rate (eMPC)
Outcomes
Primary Outcome Measures
The effectiveness of different TGC management protocols
Secondary Outcome Measures
The safety with respect to hypoglycemia
Full Information
NCT ID
NCT00764712
First Posted
October 1, 2008
Last Updated
March 9, 2012
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT00764712
Brief Title
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Official Title
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
Detailed Description
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Tight glycemia control, cardiac surgery patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Matias protocol
Arm Type
Active Comparator
Arm Description
A protocol based on the absolute glucose value - Matias protocol (Matias)
Arm Title
Bath protocol
Arm Type
Active Comparator
Arm Description
A protocol based on the relative glucose change - Bath protocol (Bath)
Arm Title
eMPC
Arm Type
Active Comparator
Arm Description
a computer-based model predictive control algorithm with variable sampling rate (eMPC)
Intervention Type
Drug
Intervention Name(s)
insulin
Other Intervention Name(s)
Actrapid HM, Novo Nordisk, Baegsvard, Denmark
Intervention Description
Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
Primary Outcome Measure Information:
Title
The effectiveness of different TGC management protocols
Time Frame
ICU stay
Secondary Outcome Measure Information:
Title
The safety with respect to hypoglycemia
Time Frame
ICU stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients admitted to the postoperative ICU after elective cardiac surgery
Exclusion Criteria:
insulin allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Blaha, MD
Organizational Affiliation
Charles University, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital in Prague
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Citations:
Citation
Blaha J, Kopecky P, Kotulak T, Kunstyr J, Matias M, Rubes D, Dobias M, Romaniv S, Kubatova J, Porizka M et al: Blood glucose control in cardiac surgery patients: a comparative study of different insulin protocols. Journal of Cardiothoracic and Vascular Anesthesia 2008, 22(S3):S23.
Results Reference
result
Learn more about this trial
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
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