Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
This study has been completed.
Sponsor:
Charles University, Czech Republic
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 1, 2008 | ||||
| Last Updated Date | March 9, 2012 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The effectiveness of different TGC management protocols [ Time Frame: ICU stay ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00764712 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The safety with respect to hypoglycemia [ Time Frame: ICU stay ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients | ||||
| Official Title ICMJE | Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients | ||||
| 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) |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hyperglycemia | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Czech Republic | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00764712 | ||||
| Other Study ID Numbers ICMJE | POINT-protocols, GAUK no. 44407 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jan Blaha, Charles University, Czech Republic | ||||
| Study Sponsor ICMJE | Charles University, Czech Republic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Charles University, Czech Republic | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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