Computerized Tight Glycemic Control in Cardiac Surgery

Not Applicable

Completed

• Conditions: Hyperglycemia

• Registration Number: NCT01886365
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-06
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-24
• Last Update Submitted: 2013-06-24
• Study First Posted: 2013-06-25
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time within a blood glucose corridor of 80 - 150 mg/dl	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 Outcome Measures

Name	Time	Method
Hypoglycemic events	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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany