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Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients

This study has been completed.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00996099
First received: October 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.


Condition Intervention
Hyperglycemia
Cardiac Surgery
Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
Other: Intensive insulin therapy using standard protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters) [ Time Frame: first 24 hours after cardiac surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range [ Time Frame: first 24 hours after cardiac surgery ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CGM-eMPC Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery
Control Other: Intensive insulin therapy using standard protocol
Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

  • insulin allergy
  • mental incapacity
  • language barrier
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996099

Locations
Czech Republic
General University Hospital
Prague, Czech Republic, 128 00
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Martin Haluzik, Prof, D.Sc. 3rd Department of Medicine, General University Hospital, Prague
  More Information

No publications provided

Responsible Party: prof. M. Haluzik, MD, D.Sc., 3rd Department of Medicine, Charles University, Prague
ClinicalTrials.gov Identifier: NCT00996099     History of Changes
Other Study ID Numbers: CGM-eMPC
Study First Received: October 15, 2009
Last Updated: October 15, 2009
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
continuous glucose monitoring
intensive insulin therapy
critically ill
cardiac surgery
hyperglycemia of critically ill

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014