NCT01146847

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

Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) in Surgical ICU Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-06-22
• Last updated: 2010-11-02

Locations

1 site across 1 country: Germany