Computerized Tight Glycemic Control in Cardiac Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01886365

Enrollment

Registered

2013-06-25

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2013-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

Computer based glycemic control, insulin, blood glucose

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.

Interventions

DEVICESpace GlucoseControl System, B. Braun, Melsungen, Germany

Computerized algorithmic application of insulin

OTHERConventional therapy with a fixed insulin dosing scheme

Routine care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026