Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/05/2005
Date assigned
21/07/2005
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J Duncan Young

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pilot Effectiveness of Randomised Mandatory Insulin Therapy (PERMIT)

Acronym

PERMIT

Study hypothesis

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

Oxford Research Ethics Committee (REC) C, ref: 05/Q1606/103

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intensive care admission

Intervention

Sliding scale insulin versus mandated insulin

Intervention type

Drug

Phase

Not Applicable

Drug names

Insulin

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/07/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/07/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Research & Development Department
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

British Journal of Anaesthesia/Royal College of Anaesthetists (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/03/2016: No publications found, verifying study status with principal investigator. 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.