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Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764712
First Posted: October 2, 2008
Last Update Posted: March 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Blaha, Charles University, Czech Republic
  Purpose
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)

Condition Intervention
Hyperglycemia Drug: insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Jan Blaha, Charles University, Czech Republic:

Primary Outcome Measures:
  • The effectiveness of different TGC management protocols [ Time Frame: ICU stay ]

Secondary Outcome Measures:
  • The safety with respect to hypoglycemia [ Time Frame: ICU stay ]

Enrollment: 120
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Matias protocol
A protocol based on the absolute glucose value - Matias protocol (Matias)
Drug: insulin
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.
Other Name: Actrapid HM, Novo Nordisk, Baegsvard, Denmark
Active Comparator: Bath protocol
A protocol based on the relative glucose change - Bath protocol (Bath)
Drug: insulin
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.
Other Name: Actrapid HM, Novo Nordisk, Baegsvard, Denmark
Active Comparator: eMPC
a computer-based model predictive control algorithm with variable sampling rate (eMPC)
Drug: insulin
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.
Other Name: Actrapid HM, Novo Nordisk, Baegsvard, Denmark

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion Criteria:

  • insulin allergy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764712


Locations
Czech Republic
University Hospital in Prague
Prague, Czech Republic
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Jan Blaha, MD Charles University, Czech Republic
  More Information

Publications:
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.

Responsible Party: Jan Blaha, Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT00764712     History of Changes
Other Study ID Numbers: POINT-protocols
GAUK no. 44407
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Jan Blaha, Charles University, Czech Republic:
Tight glycemia control
cardiac surgery patients

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs