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Feasibility of Tight Blood Glucose Control With the Space TGC System in Surgical ICU Patients (DELIOS 03)

Primary Purpose

Critical Illness

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Space TGC

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinikum Ludwigshafen am Rhein gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

(Arterial) blood glucose values -> percentage of time within predefined glucose target range 80-110 mg/dL (4.4-6.1 mM)

Secondary Outcome Measures

Hypoglycaemia ≤ 40 md/dL (2.2mM)

Usability parameters like convenience of alarming function; workload; blood sampling frequency

Concomitant medication including insulin infusion rate, parenteral/enteral nutrition

Full Information

NCT ID

NCT01146847

First Posted

June 9, 2010

Last Updated

November 1, 2010

Sponsor

B. Braun Melsungen AG

1. Study Identification

Unique Protocol Identification Number

NCT01146847

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Space TGC

Intervention Description

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)

Primary Outcome Measure Information:

Title

(Arterial) blood glucose values -> percentage of time within predefined glucose target range 80-110 mg/dL (4.4-6.1 mM)

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 72h

Secondary Outcome Measure Information:

Title

Hypoglycaemia ≤ 40 md/dL (2.2mM)

Time Frame

from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h

Title

Usability parameters like convenience of alarming function; workload; blood sampling frequency

Time Frame

from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h

Title

Concomitant medication including insulin infusion rate, parenteral/enteral nutrition

Time Frame

from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joachim Boldt, Prof. Dr. med.

Organizational Affiliation

Klinik für Anästhesiologie und Operative Intensivmedizin, Klinikum Ludwigshafen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Ludwigshafen am Rhein gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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