Computerized Tight Glycemic Control in Cardiac Surgery

NCT01886365 | Completed

• 1 other identifier: PV3388
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia

Keywords

Computer based glycemic control, insulin, blood glucose

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Hypoglycemic events

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

Study Arms (3)

Group A

ACTIVE COMPARATOR

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.

Device: Space GlucoseControl System, B. Braun, Melsungen, Germany

Group B

ACTIVE COMPARATOR

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.

Device: Space GlucoseControl System, B. Braun, Melsungen, Germany

Group C

OTHER

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).

Other: Conventional therapy with a fixed insulin dosing scheme

Interventions

Space GlucoseControl System, B. Braun, Melsungen, Germany DEVICE

Computerized algorithmic application of insulin

Group A; Group B

Conventional therapy with a fixed insulin dosing scheme OTHER

Routine care

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• B. Braun Melsungen AG: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (2)

• 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.

  PMID: 37526194 DERIVED

• 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.

  PMID: 25281044 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Daniel A Reuter, Professor

  University Medical Center Hamburg-Eppendorf, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesiology

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 25, 2013
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

DE (1)