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Computerized Tight Glycemic Control in Cardiac Surgery

NCT01886365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-06-25

No results posted yet for this study

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

Interventions

DEVICE

Space GlucoseControl System, B. Braun, Melsungen, Germany

Computerized algorithmic application of insulin

OTHER

Conventional therapy with a fixed insulin dosing scheme

Routine care

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Daniel A Reuter, Professor · University Medical Center Hamburg-Eppendorf, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886365 on ClinicalTrials.gov