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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Blaha, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00764712
First received: October 1, 2008
Last updated: March 9, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Charles University, Czech Republic:

Primary Outcome Measures:
  • The effectiveness of different TGC management protocols [ Time Frame: ICU stay ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion Criteria:

  • insulin allergy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 1, 2008
Last Updated: March 9, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014