Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)

Catholic University (KU) of Leuven

Status: Completed

Conditions: Hypoglycemia; Hyperglycemia; Critical Illness

Treatments: Device: LOGIC-Insulin algorithm; Device: Paper protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02056353

S55613 (Other Identifier)

IWT-TBM 100793 (Other Grant/Funding Number)

ML9517 (Other Identifier)

80M0563 (Other Identifier)

LOGIC-Insulin 2.1.1

Details and patient eligibility

About

Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.

Enrollment: 1,550 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted to the ICU with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line
• Patients should be 18 years or older

Exclusion criteria

• Not critically ill
• Age under 18 years
• Patients already enrolled in another intervention randomized controlled trial
• Patients expected to die within 12 hours (=moribund patients)
• No arterial line or central venous line needed
• Pregnancy or lactating
• Patients suffering from ketoacidotic or hyperosmolar coma on admission
• Patients who have been previously been included in the LOGIC-2 study
• Allergy to insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,550 participants in 2 patient groups

Nurse-directed

Active Comparator group

Description:

Blood glucose control guided by paper protocol

Treatment:

Device: Paper protocol

LOGIC-Insulin

Experimental group

Description:

Blood glucose control guided by the LOGIC-Insulin algorithm

Treatment:

Device: LOGIC-Insulin algorithm