Feasibility of Tight Blood Glucose Control With the Space TGC System in Surgical ICU Patients

Critical Illness Clinical Trial

— DELIOS 03  

Official title:

Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) in Surgical ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146847
• Other study ID #: HC-G-H-0908
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: November 1, 2010
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 tight glucose control range (4.4 to 6.1 mmol/L) in surgical intensive care patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• age: > 18 years of age

• stay in the ICU expected to be > 20 h

• blood glucose > 110 mg/dl or patient 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)

• moribund patients likely to die within 24 hours

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Space TGC
Space TGC with incorporated eMPC algorithm to establish tight glycaemic control with a blood glucose target range of 80-110 mg/dL (4.4-6.1 mM)

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen am Rhein gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin	Ludwigshafen

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Arterial) blood glucose values -> percentage of time within predefined glucose target range 80-110 mg/dL (4.4-6.1 mM)		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 72h	No
Secondary	Hypoglycaemia = 40 md/dL (2.2mM)		from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h	Yes
Secondary	Usability parameters like convenience of alarming function; workload; blood sampling frequency		from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h	No
Secondary	Concomitant medication including insulin infusion rate, parenteral/enteral nutrition		from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h	No