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

Sponsor

B. Braun Melsungen AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01233271

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Device: Space TGC	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control	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)

Arm

Intervention/Treatment

Experimental: 1

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

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)

Outcome Measures

Primary Outcome Measures

(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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)