Computerized Tight Glycemic Control in Cardiac Surgery

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886365
• Other study ID #: PV3388
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: June 24, 2013
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Device:
• Space GlucoseControl System, B. Braun, Melsungen, Germany
Computerized algorithmic application of insulin

Other:
• Conventional therapy with a fixed insulin dosing scheme
Routine care

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time within a blood glucose corridor of 80 - 150 mg/dl	The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy	From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.	No
Secondary	Hypoglycemic events	Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl	From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.	No