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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01233271 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
DELIOS 02 |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01233271 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jeremy Cordingley, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Brompton Hospital |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Critical Illness
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Intervention(s)
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Device: Space TGC
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Primary Outcome(s)
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(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]
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Secondary Outcome(s)
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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]
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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]
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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]
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Secondary ID(s)
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HC-G-H-0907
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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