Status:

COMPLETED

Closed Loop Glucose Control in Intensive Care Unit

Lead Sponsor:

University of Cambridge

Collaborating Sponsors:

European Commission

Cambridge University Hospitals NHS Foundation Trust

Conditions:

Stress Hyperglycaemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to assess the efficacy, safety and feasibility of a computer-based control algorithm to control glucose levels in adults in intensive care unit, in comparison to standard ...

Detailed Description

This will be a single centre, open-label, randomised, parallel design, feasibility study conducted at Neurosciences Critical Care Unit (NCCU), Addenbrooke's hospital, Cambridge, UK. Study will aim for...

Eligibility Criteria

Inclusion

  • Aged 18 years and older
  • Admitted to Neurosciences critical care unit; (all patients are eligible regardless of admitting diagnosis except where specified under exclusion criteria)
  • Stay in intensive care unit expected to be at least 48 hours
  • At least one of the following conditions applies:
  • Not on insulin infusion and single confirmed reference blood glucose level \> 10.0 mmol/l
  • Already on insulin infusion including those subjects with pre-existing diabetes.

Exclusion

  • Patients with diabetic ketoacidosis or hyperosmolar hyperglycaemic non-ketotic coma (HONK)
  • Patients who are receiving therapeutic hypothermia
  • 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 with significant abnormalities of blood clotting.
  • Moribund patients likely to die within 48 hours
  • Pregnancy

Key Trial Info

Start Date :

May 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2012

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT01440842

Start Date

May 1 2012

End Date

October 1 2012

Last Update

January 3 2013

Active Locations (1)

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1

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ