- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
-
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Leuven, Belgio, 3000
- Dept Intensive Care Medicine, University Hospitals Leuven
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
Altri nomi:
|
Comparatore attivo: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Glycemic Penalty Index (GPI) during the intervention
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of patients with severe hypoglycemia (<40 mg/dL) during the intervention
Lasso di tempo: 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
|
Incidence of severe hypoglycemia (<40 mg/dL) during the intervention
Lasso di tempo: 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
Lasso di tempo: up to 14 days post-randomization
|
up to 14 days post-randomization
|
|
Hyperglycemic index (HGI) during the intervention
Lasso di tempo: 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
Lasso di tempo: up to 14 days post-randomization
|
Marker of blood glucose variability
|
up to 14 days post-randomization
|
Proportion of patients with common hypoglycemia (<60 mg/dL) during the intervention
Lasso di tempo: up to 14 days post-randomization
|
Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention
|
up to 14 days post-randomization
|
Interval between blood glucose measurements during the intervention
Lasso di tempo: up to 14 days post-randomization
|
Marker of workload
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up to 14 days post-randomization
|
Percentage of time in target zone (80-110 mg/dL) during the intervention
Lasso di tempo: 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
Lasso di tempo: up to 90 days post-randomization
|
up to 90 days post-randomization
|
|
Length of stay in hospital
Lasso di tempo: up to 90 days post-randomization
|
up to 90 days post-randomization
|
|
Hospital mortality
Lasso di tempo: 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
|
Incidence of common hypoglycemia (<60 mg/dL) during the intervention
Lasso di tempo: up to 14 days post-randomization
|
Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention
|
up to 14 days post-randomization
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Dieter Mesotten, MD, PhD, KU Leuven
- Investigatore principale: Greet Van den Berghe, MD, PhD, KU Leuven
- Investigatore principale: Tom Van Herpe, Eng, PhD, KU Leuven
- Investigatore principale: Bart De Moor, Eng, PhD, KU Leuven
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LOGIC-Insulin 1.1.1.
- S 51956 (Altro identificatore: University Hospitals Leuven)
- 80M0437 (Altro identificatore: Belgian Federal Agency for Medicines and Health Products)
- ML 6079 (Altro identificatore: IRB)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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