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Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

NCT ID: NCT01523665

Last Updated: 2013-11-27

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

Total Enrollment

508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).

The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.

Detailed Description

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Conditions

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Intensive Care Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Intensive care patients who require blood glucose control by intravenous application of insulin

Exclusion:

* All contraindication of intravenous insulin therapy
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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Responsibility Role SPONSOR

Locations

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Investigational Site

Hradec Králové, , Czechia

Site Status

Investigational Site

Pilsen, , Czechia

Site Status

Investigational sites

Prague, , Czechia

Site Status

Rigshospitalet Copenhagen

Copenhagen, , Denmark

Site Status

Vejle Sygehus

Vejle, , Denmark

Site Status

Tartu University Hospital

Tartu, , Estonia

Site Status

Klinikum

Augsburg, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Investigational Site

Legnano, , Italy

Site Status

Investigational site

Siena, , Italy

Site Status

Wroclaw Medical University

Wroclaw, , Poland

Site Status

Hospital Sur,

Madrid, , Spain

Site Status

Investigational Site

Jönköping, , Sweden

Site Status

Investigational Site

Södertälje, , Sweden

Site Status

Investigational Site

Stockholm, , Sweden

Site Status

West Suffolk Hospital

Bury Saint Edmonds, , United Kingdom

Site Status

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

Countries

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Czechia Denmark Estonia Germany Italy Poland Spain Sweden United Kingdom

References

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Blaha J, Barteczko-Grajek B, Berezowicz P, Charvat J, Chvojka J, Grau T, Holmgren J, Jaschinski U, Kopecky P, Manak J, Moehl M, Paddle J, Pasculli M, Petersson J, Petros S, Radrizzani D, Singh V, Starkopf J. Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study. BMC Anesthesiol. 2016 Jan 22;16:8. doi: 10.1186/s12871-016-0175-4.

Reference Type DERIVED
PMID: 26801983 (View on PubMed)

Other Identifiers

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HC-O-H-1102

Identifier Type: -

Identifier Source: org_study_id