Critical Illness, Hyperglycemia, Hypoglycemia
Conditions
Keywords
Software, Algorithm, Cardiac surgery
Brief summary
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.
Interventions
DEVICELOGIC-Insulin algorithm
DEVICEPaper protocol
Sponsors
Agentschap voor Innovatie door Wetenschap en Technologie
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Penalty Index (GPI) during the Intervention | up to 14 days post-randomization | Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention | up to 14 days post-randomization | Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention |
| Blood Glucose Level Per Treatment Group during the Intervention | up to 14 days post-randomization | Mean and median arterial blood glucose level |
| Hyperglycaemic index (HGI) | up to 14 days post-randomization | Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI) |
| Time in target range | up to 14 days post-randomization | — |
| Time to target range | up to 14 days post-randomization | — |
| Daily maximal blood glucose difference | up to 14 days post-randomization | marker of blood glucose fluctuations |
| Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention | up to 14 days post-randomization | Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention |
| Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention | up to 14 days post-randomization | Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention |
| Interval between blood glucose measurements | up to 14 days post-randomization | marker of workload |
| Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention | up to 14 days post-randomization | Proportion of patients to have had one or more episodes of severe hypoglycaemia (\<40 mg/dL) during the intervention |
| Overrules in the intervention group | up to 14 days post-randomization | the number and proportions of recommendations by the software that were overruled by the bed-side nurses * Minor overrules: absolute insulin dose difference of \>0.1 and \< 1IU/h * Major overrules: absolute insulin dose difference of \>= 1IU/h * Major overrules will also be qualitatively assessed |
| Incidence of new infections in the ICU | up to 90 days post-randomization | The diagnosis of new infection will be based on the administration of antibiotics, beyond the prophylactic scope |
| Length of stay in the ICU | up to 90 days post-randomization | — |
| Length of stay in the hospital | up to 90 days post-randomization | — |
| Mortality in the ICU | up to 90 days post-randomization | — |
| Mortality in the hospital | up to 90 days post-randomization | — |
| Landmark 90-day mortality | up to 90 days post-randomization | — |
| All direct medical costs from a healthcare payer's perspective | up to 90 days post-randomization | — |
| Quality of Life | up to 90 days post-randomization | EuroQol-5D |
| Protocol compliance in the intervention group | up to 14 days post-randomization | the number and proportion of patients in which the LOGIC-Insulin was not followed for a time period of at least 8 hours, which is the duration of one nurse shift. |
Countries
Belgium, Netherlands
Outcome results
None listed