Impact of Tight blood Glucose Control within normal fasting ranges with insulin titration prescribed by the Leuven algorithm in adult critically ill patients

Phase 1

• Conditions: Hyperglycemia in critically ill patients (stress hyperglycemia); MedDRA version: 20.1Level: LLTClassification code 10042216Term: Stress induced hyperglycemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-000756-17-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-07
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 9230

Inclusion Criteria

Adult (=18 years of age) patient admitted to one of the participating intensive care units
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 4300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4930

Exclusion Criteria

- Patients with a DNR (do not resuscitate) order at the time of ICU admission
- Patients expected to die within 12 hours after ICU admission (= moribund patients)
- Patients able to receive oral feeding (not critically ill)
- Patients without arterial and without central venous line and without imminent need to place it as part of ICU management (not critically ill)
- Patients previously included in the trial (when readmission is within 48 hours post ICU discharge, the trial intervention will be resumed)
- Patients already enrolled in another randomized controlled trial (RCT) powered for clinical endpoints
- Patients transferred from a non-participating ICU with a pre-admission ICU stay >7 days
- Patients planned to receive parenteral nutrition during the first week in ICU
- Patients suffering from diabetic ketoacidotic or hyperosmolar coma on ICU admission
- Patients with inborn metabolic diseases
- Patients with insulinoma
- Patients known to be pregnant or lactating
- No informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified