Computerized Tight Glycemic Control in Cardiac Surgery

NCT ID: NCT01886365

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

With start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge.

Group Type: ACTIVE_COMPARATOR

Space GlucoseControl System, B. Braun, Melsungen, Germany

Intervention Type: DEVICE

Computerized algorithmic application of insulin

Group B

Corresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes.

Group Type: ACTIVE_COMPARATOR

Space GlucoseControl System, B. Braun, Melsungen, Germany

Intervention Type: DEVICE

Computerized algorithmic application of insulin

Group C

With start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was \> 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care).

Group Type: OTHER

Conventional therapy with a fixed insulin dosing scheme

Intervention Type: OTHER

Routine care

Interventions

Space GlucoseControl System, B. Braun, Melsungen, Germany

Computerized algorithmic application of insulin

Intervention Type: DEVICE

Conventional therapy with a fixed insulin dosing scheme

Routine care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Daniel Reuter

Professor of anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A Reuter, Professor

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf, Germany

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

References

Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

Reference Type: DERIVED

PMID: 37526194 (View on PubMed)

Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1273-7. doi: 10.1053/j.jvca.2014.04.017.

Reference Type: DERIVED

PMID: 25281044 (View on PubMed)

Other Identifiers

PV3388

Identifier Type: -

Identifier Source: org_study_id