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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00188-35 | Other Identifier | ID-RCB number, ANSM |
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This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard infusion line | Other | The standard insulin infusion system consisted in regular human insulin administration through a six-stopcock manifold connected to the distal line of a multilumen central venous catheter by 150 cm tubing. Insulin was systematically infused by syringe pump on the patient proximal port of the manifold. Carrier was infused via pump through the manifold. All others medicines were infused through the other five stopcocks. |
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| Optimised infusion line | Experimental | The optimised insulin infusion system consisted in regular human insulin administration through a multilumen device (Edelvaiss Multiline-8, Doran International, Toussieu, France). This device had ports for eight infusions which run through separate channels within a 150 cm flexible plastic tube. Since fluids from the individual channels do not meet until they exit the distal tip. Carrier was infused through the high flow (HF) line and insulin was infused by syringe pump systematically next to the HF line port. All others medicines were administered via adjacent ports on the Multiline-8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edelvaiss Multiline-8 | Device | Optimised infusion line |
| |
| Measure | Description | Time Frame |
|---|---|---|
| index GLI (Glycemic Lability Index) | This index is calculated from capillary blood glucose. | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoglycaemic events | Prevalence and incidence of hypoglycemia | 48 hours |
| Number of hyperglycaemic events | Prevalence and incidence of hyperglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lebuffe, MD, PhD | University Hospital of Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Claude Huriez - CHU de Lille | Lille | Nord | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28699150 | Result | Genay S, Decaudin B, Ethgen S, Alluin A, Babol E, Labreuche J, Behal H, Vantyghem MC, Odou P, Lebuffe G. Effect of insulin infusion line on glycaemic variability in a perioperative high dependency unit (HDU): a prospective randomised controlled trial. Ann Intensive Care. 2017 Dec;7(1):74. doi: 10.1186/s13613-017-0298-x. Epub 2017 Jul 11. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
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| Standard infusion line |
| Device |
|
| 48 hours |
| Sequential Organ Failure Assessment score (SOFA) | for measure morbidity and mortality | during the 4 days of hospitalization period |
| length of stay in Intensive Care Unit (ICU) or in hospital | for measure morbidity and mortality | during the 4 days of hospitalization period |
| Death rate | for measure morbidity and mortality | during the 4 days of hospitalization period |
| Mean Amplitude Glycemic Excusions score (MAGE) | Glycaemic variability | every 3 hours during 48 hours |
| standard deviation of blood glucose | Glycaemic variability | every 3 hours during 48 hours |
| average blood glucose | Glycaemic variability | every 3 hours during 48 hours |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |