Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
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Purpose
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.
| Condition |
|---|
|
Intensive Care Patients |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System |
- Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
- Frequency of hypoglycaemic episodes [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: Yes ]
- Adherence to the advice of the SGC system [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
- Blood glucose measurement interval [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
adult patients
Inclusion:
- Intensive care patients who require blood glucose control by intravenous application of insulin
Exclusion:
- All contraindication of intravenous insulin therapy
Contacts and Locations| Contact: Study Manager | +49(0)5661710 | studies@bbraun.com |
| Czech Republic | |
| Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic | |
| Contact: Study Manager | |
| Investigational Site | Recruiting |
| Plzen, Czech Republic | |
| Contact: Study Manager | |
| Investigational sites | Recruiting |
| Prague, Czech Republic | |
| Contact: Study Manager | |
| Italy | |
| Investigational site | Recruiting |
| Siena, Italy | |
| Contact: Study Manager | |
| Sweden | |
| Investigational Site | Recruiting |
| Jönköping, Sweden | |
| Contact: Study Manager | |
| Investigational Site | Recruiting |
| Solna, Sweden | |
| Contact: Study Manager | |
| Investigational Site | Not yet recruiting |
| Södertälje, Sweden | |
| Contact: Study Manager | |
More Information
No publications provided
| Responsible Party: | B. Braun Melsungen AG |
| ClinicalTrials.gov Identifier: | NCT01523665 History of Changes |
| Other Study ID Numbers: | HC-O-H-1102 |
| Study First Received: | January 26, 2012 |
| Last Updated: | January 30, 2012 |
| Health Authority: | Italy: Ethics Committee |
ClinicalTrials.gov processed this record on May 21, 2013