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Completed

NCT Number: NCT01886365

Computerized Tight Glycemic Control in Cardiac Surgery

The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

About this study

Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia

Exclusion criteria

  • under 18 years of age, or if patients had a premedical history of steroid therapy

Treatment and study plan

Space GlucoseControl System, B. Braun, Melsungen, Germany

Device

Computerized algorithmic application of insulin

Conventional therapy with a fixed insulin dosing scheme

Other

Routine care

Primary outcomes

  1. Time within a blood glucose corridor of 80 - 150 mg/dl

    Time frame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.

    The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy

Secondary outcomes

  1. Hypoglycemic events

    Time frame: From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.

    Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study title

Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 25, 2013
Registry last updated
Jun 25, 2013

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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