INTRODUZIONE AL PRECONDIZIONAMENTO
6.1 MATERIALI E METOD
I - Obiettivo
Lo studio è volto a valutare:
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l’efficacia del precondizionamento ischemico remoto all’arto superiore nella prevenzione del danno renale acuto da mezzo di contrasto durante interventi di rivascolarizzazione.II - Durata dello studio
La raccolta delle informazioni dei pazienti inizierà nel momento in cui il Comitato Etico competente darà l’approvazione del protocollo. Lo studio si protrarrà il tempo necessario alla raccolta. La durata complessiva dello studio sarà di 10 mesi. É verosimile che saranno necessari 8 mesi per la raccolta dei dati e 2 mesi per la loro analisi. La preparazione del manoscritto sarà successiva all’analisi dei dati disponibili.
III - Popolazione
Lo studio prevede il reclutamento di due braccia di pazienti ricoverati presso la U.O. di Diabetologia che rispondano ai criteri di inclusione e di esclusione elencati di seguito.
IV - Criteri di Inclusione
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Età maggiore di 18 anni-
Pazienti in grado di rilasciare il proprio consenso-
Pazienti ricoverati presso la U.O. di diabetologia-
Pazienti con vasculopatia diabetica che necessitano un intervento di rivascolarizzazione in angiografia interventistica.V - Criteri di Esclusione - Terapia con glibenclamide
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Età minore di 18 anni-
Rifiuto del consenso informato da parte dell’avente diritto-
Paziente che non necessita di somministrazione di mezzo di contrasto-
Qualsiasi altra condizione clinica non ritenuta idonea dagli sperimentatori VI - Criteri di uscitaRitiro del consenso informato, in qualsiasi momento, da parte dell’avente diritto
VII - Schema dello studio
Studio pilota monocentrico non sponsorizzato che prevede la formazione di due bracci di pazienti.
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Braccio A: Ai pazienti verrà richiesto un esame della Creatinina Urinaria e plasmatica pre procedurale. Successivamente verrà eseguito il precondizionamento ischemico remoto mediante un bracciale automatico che eseguire 3 cicli di 5 minuti di ischemia (con pressione superiore di 20 mmHg della sistolica) alternati ad altrettanti cicli di riperfusione. Il paziente verrà condotto in angiografia interventistica dove sarà sottoposto all’intervento di rivascolarizzazione mediante stenting e controllo contrastografico. 24 ore dopo la procedura verrà richiesta una nuova misurazione della creatina urinaria e plasmatica-
Braccio B: I pazienti seguiranno il normale iter procedurale senza essere sottoposti a precondizionamento. verrà comunque richiesta una misurazione della creatina urinaria e plasmatica pre procedurale e a 24 ore da essa.RISULTATI
In una Review pubblicata su Cardiovascular Research nel 200810 sono ben riassunti i meccanismi molecolari che ad oggi s’ ipotizza costituiscano la base del Precondizionamento Ischemico nonché le applicazioni cliniche che sostanzialmente ad
oggi se ne fanno. Prima di tutto risulta evidente come l’utilizzo di questa procedura sia, per il momento, inevitabilmente circoscritto a procedure svolte in regime d’elezione. Questo poiché, trovandoci ancora molto lontani dal raggiungimento d’indicazioni certe e sicurezza del valore della procedura, sono necessari studi che consentano di monitorare la funzionalità d’organo in circostanze controllate con presupposti clinici, laboratoristici e chirurgici ben noti. Tutto ciò in regime d’urgenza/emergenza risulta difficoltoso.
In questo senso nel nostro studio si sono considerate le medesime circostanze trattandosi di pazienti fondamentalmente stabili e conosciuti dal punto di vista anamnestico e chirurgico. L’intento ultimo dello studio, ovvero quello di poter vedere un’entrata nella pratica anestesiologico-chirurgica del RIPC con significato nefro-protettivo, ben concorda con la letteratura sinora prodotta sul tema in termini di applicazione in regime d’elezione e non d’urgenza.
E’ noto ad oggi che il RIPC è effettivamente in grado di prevenire il danno miocardico, migliorare la performance delle vie aeree e ridurre la necessità di sostegno emodinamico in pazienti pediatrici ed in pazienti adulti sottoposti a CABG. Per quanto riguarda il danno renale è altresì dimostrato che il RIPC è in grado di offrire nefro e cardio-protezione in corso d’interventi di riparazione di aneurisma dell’aorta addominale.
Il nostro lavoro ha permesso di valutare come il RIPC sia in grado di offrire nefroprotezione in quei pazienti in lista per interventi di rivascolarizzazione.
Questo tipo di pazienti per la loro patologia di base purtroppo saranno sempre soggetti a questo tipo di intervento. La RIPC avrà lo scopo di ritardare il più possibile l’instaurassi di AKI.
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BASI DEL PRECONDIZIONAMENTO
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