Pilot Effectiveness of Randomised Mandatory Insulin Therapy - PERMIT study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001693-27-GB

Enrollment

120

Registered

2005-04-20

Start date

2005-06-24

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Those admitted to the Intensive Care Unit for treatment and likely to remain on the unit for longer than 5 days.

Interventions

Trade Name: ACTRAPID Product Name: ACTRAPID Product Code: ACTRAPID Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Insuli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Is the patient 16 years or older? 2. Is the patient deemed by the attending physician to require 5 or more days of critical care treatment? Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 3. Is the patient known to have diabetes mellitus? 4. Has the patient been admitted with diabetic ketoacidosis? 5. Does the patient have a current diagnosis of pancreatitis? 6. Has the patient undergone hepato-biliary surgery in the current admission? 7. Does the patient have an insulinoma or pituitary tumour? 8. Is the patient on TPN? 9. Is the patient pregnant? 10. Is the patient being treated for a primary diagnosis of head injury? 11. Has the patient been admitted with an acute stoke or intracranial bleed? 12. Is the patient enrolled in another study? 13. Is the patient currently under section? 14. Does the patient have a learning disability? 15. Is the patient/ relative unable to speak English or not able to understand written or oral information (and no translator is available)?

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary goal of the clinical trial is in a single centre pilot study assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. ;Primary end point(s): The primary outcome is the number of episodes of hypoglycaemia per unit length of stay in the ICU.; Secondary Objective: The secondary goals to investigate four of the possible mechanisms by which endogenous insulin might alter outcome. -Effects on lipid profiles -Effects on nitrogen balance -Effects on insulin-like growth factor and its biding proteins -Effects on oxidative damage by measuring protein carbonyls.	—

Measure

Time frame

Main Objective: The primary goal of the clinical trial is in a single centre pilot study assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. ;Primary end point(s): The primary outcome is the number of episodes of hypoglycaemia per unit length of stay in the ICU.; Secondary Objective: The secondary goals to investigate four of the possible mechanisms by which endogenous insulin might alter outcome. -Effects on lipid profiles -Effects on nitrogen balance -Effects on insulin-like growth factor and its biding proteins -Effects on oxidative damage by measuring protein carbonyls.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026