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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764712
• Other study ID #: POINT-protocols
• Secondary ID: GAUK no. 44407
• Status: Completed
• Phase: N/A
• First received: October 1, 2008
• Last updated: March 9, 2012
• Start date: February 2008
• Est. completion date: April 2008

Study information

• Verified date: March 2012
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion Criteria:

• insulin allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	University Hospital in Prague	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

References & 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 An

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of different TGC management protocols		ICU stay	No
Secondary	The safety with respect to hypoglycemia		ICU stay	Yes