Pilot effectiveness of randomised mandatory insulin therapy
| ISRCTN | ISRCTN00550641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00550641 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
University/education
British Journal of Anaesthesia/Royal College of Anaesthetists (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
