Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
2 other identifiers
interventional
120
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2008
Shorter than P25 for not_applicable
1 active site
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
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedMarch 12, 2012
March 1, 2012
2 months
October 1, 2008
March 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effectiveness of different TGC management protocols
ICU stay
Secondary Outcomes (1)
The safety with respect to hypoglycemia
ICU stay
Study Arms (3)
Matias protocol
ACTIVE COMPARATORA protocol based on the absolute glucose value - Matias protocol (Matias)
Bath protocol
ACTIVE COMPARATORA protocol based on the relative glucose change - Bath protocol (Bath)
eMPC
ACTIVE COMPARATORa computer-based model predictive control algorithm with variable sampling rate (eMPC)
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients admitted to the postoperative ICU after elective cardiac surgery
You may not qualify if:
- insulin allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital in Prague
Prague, Czechia
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Blaha, MD
Charles University, Czech Republic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
February 1, 2008
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
March 12, 2012
Record last verified: 2012-03