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Feasibility of Tight Blood Glucose Control With the Space TGC System in Surgical ICU Patients

NCT ID: NCT01146847

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-06-30

Brief Summary

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Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/L) in surgical intensive care patients.

Detailed Description

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Conditions

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Critical Illness

Keywords

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algorithm tight glycemic control glucose control intensive care insulin ICU

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Space TGC system with incorporated eMPC advised insulin titration to establish tight glycaemic control

Group Type EXPERIMENTAL

Space TGC

Intervention Type DEVICE

Space TGC with incorporated eMPC algorithm to establish tight glycaemic control with a blood glucose target range of 80-110 mg/dL (4.4-6.1 mM)

Interventions

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Space TGC

Space TGC with incorporated eMPC algorithm to establish tight glycaemic control with a blood glucose target range of 80-110 mg/dL (4.4-6.1 mM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age: \> 18 years of age
* stay in the ICU expected to be \> 20 h
* blood glucose \> 110 mg/dl or patient on insulin treatment

Exclusion:

* patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* known or suspected allergy to insulin
* any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* moribund patients likely to die within 24 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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B. Braun Melsungen AG

Principal Investigators

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Joachim Boldt, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie und Operative Intensivmedizin, Klinikum Ludwigshafen

Locations

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Klinikum Ludwigshafen am Rhein gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Ludwigshafen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HC-G-H-0908

Identifier Type: -

Identifier Source: org_study_id