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

Critical Illness Clinical Trial

— DELIOS 02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233271
• Other study ID #: HC-G-H-0907
• Status: Completed
• Phase: N/A
• First received: November 2, 2010
• Last updated: June 8, 2011
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• age: > 18 years of age

• admitted following cardiac surgery

• stay in the ICU expected to be > 20 h

• blood glucose > 6.7 mmol/l within 4 hours of ICU admission or patient already 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)

• patients participating in another study

• moribund patients likely to die within 24 hours

• patients after organ transplantation within the last three months

• patients under high dose cortisol treatment (cortisol > 1000 mg/day or equivalent doses of hydrocortisol)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital, Intensive Care Medicine	London

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL		all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h	No
Secondary	Hypoglycaemia = 40 md/dL (2.2mM)		all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h	Yes
Secondary	Usability parameters like convenience of alarming function; workload; blood sampling frequency		all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h	No
Secondary	Concomitant medication including insulin infusion rate, parenteral/enteral nutrition		all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h	No