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

NCT01233271 | Completed

• 1 other identifier: HC-G-H-0907
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

algorithm; tight glycemic control; glucose control; intensive care; insulin; ICU

Outcome Measures

Primary Outcomes (1)

• (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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

1

EXPERIMENTAL

Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control

Device: Space TGC

Interventions

Space TGC DEVICE

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)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (1)

Royal Brompton Hospital, Intensive Care Medicine

London, SW3 6NP, United Kingdom

Location

Related 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.

  PMID: 18661120 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeremy Cordingley, Dr.

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

GB (1)