NCT01233271

Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU

Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the ICU

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• 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 extended glucose control range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DEVICE	Space TGC	Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-11-03
• Last updated: 2011-06-09

Locations

1 site across 1 country: United Kingdom