Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU (DELIOS 02)

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01233271
First received: November 2, 2010
Last updated: June 8, 2011
Last verified: June 2011

November 2, 2010
June 8, 2011
November 2010
April 2011   (final data collection date for primary outcome measure)
(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01233271 on ClinicalTrials.gov Archive Site
  • Hypoglycaemia ≤ 40 md/dL (2.2mM) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Usability parameters like convenience of alarming function; workload; blood sampling frequency [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Concomitant medication including insulin infusion rate, parenteral/enteral nutrition [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Critical Illness
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)
Experimental: 1
Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control
Intervention: Device: Space TGC
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. Epub 2008 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2011
April 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01233271
HC-G-H-0907
No
Study Manager, B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Principal Investigator: Jeremy Cordingley, Dr. Royal Brompton Hospital
B. Braun Melsungen AG
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP