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ISRCTN
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ISRCTN00550641
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ClinicalTrials.gov identifier
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Public title
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Pilot Effectiveness of Randomised Mandatory Insulin Therapy
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Scientific title
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Acronym
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PERMIT study
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Serial number at source
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N/A
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Study hypothesis
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As of 23/07/2009 this record was extensively updated to include changes that took place to the protocol before trial completion. All updates can be found under the relevant section with the above update date.
Current information as of 23/07/2009:
In patients requiring more than 48 hours of critical care treatment, mandatory insulin therapy, in comparison to usual sliding scale insulin therapy will not alter glycaemic control (including the number of severe hypoglycaemic events), but will modulate the derangements in the somatotrophic axis seen in critically ill patients.
Initial information at time of registration:
In patients requiring 5 or more days of critical care treatment, giving mandatory insulin therapy, compared to usual sliding scale insulin therapy as required, the number of severe hypoglycaemic events will be unchanged.
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Ethics approval
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Added 23/07/2009: Oxford Research Ethics Committee (REC) C approved (ref: 05/Q1606/103)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Intensive care admission
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Participants - inclusion criteria
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Current information as of 23/07/2009:
Adult patients likely to remain on the intensive care unit (ICU) for greater than 48 hours.
Initial information at time of registration:
Adult patients likely to remain on the intensive care unit (ICU) for greater than 5 days
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Participants - exclusion criteria
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1. Patients known to have diabetes mellitus
2. Patients admitted with diabetic ketoacidosis
3. Patients with a current diagnosis of pancreatitis
4. Patients who have undergone hepato-biliary surgery in the current admission
5. Patients with an insulinoma or pituitary tumour
6. Patients currently on, or likely to require, total parenteral nutrition
7. Patients who are pregnant
8. Patients with a primary diagnosis of head injury
9. Patients with a primary diagnosis of intracranial haemorrhage
10. Patients with a primary diagnosis of stroke
11. Inclusion in another study
12. Patients currently placed under a section order
13. Patients with a learning disability
14. Patients/relatives unable to speak English and without a suitable translator
15. Patients already on higher than 4 units of insulin per hour and have been so for at least 3 out of the last 24 hours
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Anticipated start date
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01/07/2005
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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Sliding scale insulin versus mandated insulin
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Primary outcome measure(s)
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Current information as of 23/07/2009:
1. Glycaemic control (measured as proportion of hyperglycaemic time, number of severe hypoglycaemic episodes per patient).
2. Effects on the somatotrophic axis
Initial information at time of registration:
Number of episodes of hypoglycaemia per unit length of stay in the ICU.
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Secondary outcome measure(s)
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Current information as of 23/07/2009:
1. Biochemical markers:
1.1. The number of patients undergoing a hypoglycaemic episode and the number of hypoglycaemic episodes whilst receiving the study protocol
1.2. The number of patients undergoing a hypokalaemic episode and the number of hypokalaemic episodes whilst receiving the study protocol
1.3. Plasma concentrations of IGF-1, IGF-2, IGFBP-1, IGFBP-3, GH at baseline and on days 3,5, 8 and 15 of ICU stay
1.4. Plasma concentrations of HDL, LDL, TG's, FFA's at baseline and at days 3, 5 and 8 and 15 of ICU stay
1.5. The difference between nitrogen excretion (as urinary urea) and nitrogen intake (as enteral or parenteral nutrition) on days 3, 5 and 8 of ICU stay
1.6. Plasma protein carbonyl quantification on days 1, 3, 5, 8 and 15 of ICU stay
2. Morbidity and mortality:
2.1. ICU length of stay
2.2. Antibiotic free days
2.3. 30 day mortality
3. Markers of protocol compliance:
3.1. Time-weighted average blood glucose concentration
3.2. Time-weighted average serum potassium concentration
3.3. Time-weighted average insulin infusion and total insulin delivered
Initial information at time of registration:
1. Biochemical markers:
1.1. The number of episodes of hypokalaemia per unit length of stay in the ICU
1.2. The plasma levels of IGF-1, IGFBP-1, IGFBP-3, ALS on days 1, 3, 5, 8 and 15 of ICU stay
1.3. The plasma HDL, LDL and triglycerides on days 1, 3, 5, 8 and 15 of ICU stay
1.4. The plasma levels of free fatty acids on days 1, 3, 5, 8 and 15 of ICU stay
1.5. The difference between nitrogen excretion (as urinary urea) and nitrogen intake (as enteral or parenteral nutrition) on days 1, 3, 5, 8 and 15 of ICU stay
1.6. Plasma protein carbonyl quantification on days 1, 3, 5, 8 and 15 of ICU stay
2. Surrogate markers for improved long term outcome:
2.1. ICU length of stay
2.2. Hospital length of stay
2.3. Antibiotic free days (as a measure of nosocomial infection)
3. Mortality:
3.1. ICU mortality
3.2. 30 day mortality
3.3. Hospital mortality
4. Markers of protocol compliance:
4.1. Time-weighted average blood glucose concentration
4.2. Time-weighted average serum potassium concentration
4.3. Time-weighted average insulin infusion and total insulin delivered
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Sources of funding
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British Journal of Anaesthesia/Royal College of Anaesthetists (UK)
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Trial website
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Publications
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Contact name
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Dr
J Duncan
Young
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Address
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Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Sponsor
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Address
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Research & Development Department
Manor House
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Date applied
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23/05/2005
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Last edited
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04/08/2009
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Date ISRCTN assigned
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21/07/2005
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