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Completed

NCT Number: NCT00764712

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

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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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital in Prague

Prague, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion criteria

  • insulin allergy

Treatment and study plan

Insulin

Drug

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 names: Actrapid HM, Novo Nordisk, Baegsvard, Denmark

Primary outcomes

  1. The effectiveness of different TGC management protocols

    Time frame: ICU stay

Secondary outcomes

  1. The safety with respect to hypoglycemia

    Time frame: ICU stay

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2008
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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