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

B. Braun

Status: Completed

Conditions: Critical Illness

Treatments: Device: Space TGC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233271

HC-G-H-0907

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Device: Space TGC