- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01420302
LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-1)
LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
- Withdrawal of the informed consent
- Patient starts eating or drinking sugar containing liquids
- Patient is discharged from the ICU (including ICU deaths)
- Removal of arterial line or central venous line
Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:
- Recurrent severe hypoglycemia (<40 mg/dL)
- Refractory hyperglycemia
- Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician
The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Leuven, Belgien, 3000
- Dept Intensive Care Medicine, University Hospitals Leuven
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 18 years or more
- Admitted to the ICU
- Already receiving or needing insulin infusion for blood glucose control
Exclusion Criteria:
- Not critically ill (eating, not mechanically ventilated)
- Pregnant or breastfeeding
- Previous inclusion into the trial
- Included in other trial
- Moribund
- Diabetes coma
- No arterial line available
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
|
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
Andre navne:
|
Aktiv komparator: Nurse-directed
Nurse-directed blood glucose control (80-110 mg/dL)
|
Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Glycemic Penalty Index (GPI) during the intervention
Tidsramme: up to 14 days post-randomization
|
Adequacy of reaching and maintaining the target range for blood glucose during the intervention
|
up to 14 days post-randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients with severe hypoglycemia (<40 mg/dL) during the intervention
Tidsramme: up to 14 days post-randomization
|
Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention
|
up to 14 days post-randomization
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Incidence of severe hypoglycemia (<40 mg/dL) during the intervention
Tidsramme: up to 14 days post-randomization
|
Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention
|
up to 14 days post-randomization
|
Blood glucose level per treatment group during the intervention
Tidsramme: up to 14 days post-randomization
|
up to 14 days post-randomization
|
|
Hyperglycemic index (HGI) during the intervention
Tidsramme: up to 14 days post-randomization
|
Adequacy of reaching and maintaining the target range for blood glucose during the intervention
|
up to 14 days post-randomization
|
Daily maximal blood glucose difference during the intervention
Tidsramme: up to 14 days post-randomization
|
Marker of blood glucose variability
|
up to 14 days post-randomization
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Proportion of patients with common hypoglycemia (<60 mg/dL) during the intervention
Tidsramme: up to 14 days post-randomization
|
Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention
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up to 14 days post-randomization
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Interval between blood glucose measurements during the intervention
Tidsramme: up to 14 days post-randomization
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Marker of workload
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up to 14 days post-randomization
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Percentage of time in target zone (80-110 mg/dL) during the intervention
Tidsramme: up to 14 days post-randomization
|
Adequacy of reaching and maintaining the target range for blood glucose during the intervention
|
up to 14 days post-randomization
|
Length of stay in ICU
Tidsramme: up to 90 days post-randomization
|
up to 90 days post-randomization
|
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Length of stay in hospital
Tidsramme: up to 90 days post-randomization
|
up to 90 days post-randomization
|
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Hospital mortality
Tidsramme: up to 90 days post-randomization
|
Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors
|
up to 90 days post-randomization
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Incidence of common hypoglycemia (<60 mg/dL) during the intervention
Tidsramme: up to 14 days post-randomization
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Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention
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up to 14 days post-randomization
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Dieter Mesotten, MD, PhD, KU Leuven
- Ledende efterforsker: Greet Van den Berghe, MD, PhD, KU Leuven
- Ledende efterforsker: Tom Van Herpe, Eng, PhD, KU Leuven
- Ledende efterforsker: Bart De Moor, Eng, PhD, KU Leuven
Publikationer og nyttige links
Generelle publikationer
- van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Van Herpe T, De Brabanter J, Beullens M, De Moor B, Van den Berghe G. Glycemic penalty index for adequately assessing and comparing different blood glucose control algorithms. Crit Care. 2008;12(1):R24. doi: 10.1186/cc6800. Epub 2008 Feb 26.
- Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. doi: 10.1016/j.bpa.2008.07.003.
- Van Herpe T, Mesotten D, Wouters PJ, Herbots J, Voets E, Buyens J, De Moor B, Van den Berghe G. LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness: the LOGIC-1 single-center, randomized, controlled clinical trial. Diabetes Care. 2013 Feb;36(2):188-94. doi: 10.2337/dc12-0584. Epub 2012 Sep 6.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LOGIC-Insulin 1.1.1.
- S 51956 (Anden identifikator: University Hospitals Leuven)
- 80M0437 (Anden identifikator: Belgian Federal Agency for Medicines and Health Products)
- ML 6079 (Anden identifikator: IRB)
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