Pilot effectiveness of randomised mandatory insulin therapy

ISRCTN	ISRCTN00550641
DOI	https://doi.org/10.1186/ISRCTN00550641
Protocol serial number	N/A
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	British Journal of Anaesthesia/Royal College of Anaesthetists (UK)

Submission date: 23/05/2005
Registration date: 21/07/2005
Last edited: 12/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J Duncan Young
Scientific

Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Pilot Effectiveness of Randomised Mandatory Insulin Therapy (PERMIT)
Study acronym	PERMIT
Study objectives	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.
Ethics approval(s)	Oxford Research Ethics Committee (REC) C, ref: 05/Q1606/103
Health condition(s) or problem(s) studied	Intensive care admission
Intervention	Sliding scale insulin versus mandated insulin
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Insulin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/07/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/03/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/03/2018: Publication reference added.

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.