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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01233271
First received: November 2, 2010
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Critical Illness
 Device: Space TGC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • (arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycaemia ≤ 40 md/dL (2.2mM) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Usability parameters like convenience of alarming function; workload; blood sampling frequency [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Concomitant medication including insulin infusion rate, parenteral/enteral nutrition [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233271

Locations
United Kingdom
Royal Brompton Hospital, Intensive Care Medicine
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Jeremy Cordingley, Dr. Royal Brompton Hospital
  More Information

Publications:

Responsible Party: Study Manager, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01233271     History of Changes
Other Study ID Numbers: HC-G-H-0907
Study First Received: November 2, 2010
Last Updated: June 8, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by B. Braun Melsungen AG:
algorithm
tight glycemic control
glucose control
 intensive care
insulin
ICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013