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

Overview

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)

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2008

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Matias protocol
    • A protocol based on the absolute glucose value – Matias protocol (Matias)
  • Active Comparator: Bath protocol
    • A protocol based on the relative glucose change – Bath protocol (Bath)
  • Active Comparator: eMPC
    • a computer-based model predictive control algorithm with variable sampling rate (eMPC)

Clinical Trial Outcome Measures

Primary Measures

  • The effectiveness of different TGC management protocols
    • Time Frame: ICU stay

Secondary Measures

  • The safety with respect to hypoglycemia
    • Time Frame: ICU stay

Participating in This Clinical Trial

Inclusion Criteria

  • patients admitted to the postoperative ICU after elective cardiac surgery Exclusion Criteria:

  • insulin allergy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charles University, Czech Republic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jan Blaha, Principal Investigator – Charles University, Czech Republic
  • Overall Official(s)
    • Jan Blaha, MD, Principal Investigator, Charles University, Czech Republic

Citations Reporting on Results

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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