Clinical trial NCT01233271: Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: algorithm
tight glycemic control
glucose control
intensive care
insulin
ICU
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: (arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL
timeFrame: 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
Secondary outcomes:
measure: Hypoglycaemia ≤ 40 md/dL (2.2mM)
timeFrame: 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
measure: Usability parameters like convenience of alarming function; workload; blood sampling frequency
timeFrame: 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
measure: Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
timeFrame: 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
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Intensive Care Medicine
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Jeremy Cordingley, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.