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001-es BibID:	BIBFORM082674
Első szerző:	Zádori Noémi
Cím:	EarLy elimination of fatty acids iN hypertriglyceridemia-induced acuTe pancreatitis (ELEFANT trial) : protocol of an open-label, multicenter, adaptive randomized clinical trial / Noémi Zádori, Noémi Gede, Judit Antal, Andrea Szentesi, Hussain Alizadeh, Áron Vincze, Ferenc Izbéki, Mária Papp, László Czakó, Márta Varga, Enrique de-Madaria, Ole H. Petersen, Vijay P. Singh, Julia Mayerle, Nándor Faluhelyi, Attila Miseta, István Reiber, Péter Hegyi
Dátum:	2020
ISSN:	1424-3903
Megjegyzések:	Introduction: Acute pancreatitis (AP) is a life-threatening inflammatory disease, with no specific pharmacologi- cal treatment. However, concerning some etiologies, early specific intervention (such as ERCP in biliary AP) has proven to be remarkably beneficial. Hypertriglyceridemia (HTG) induces severe pancreatic damage by several direct (cellular damage) and indirect (deterioration of microcirculation) mechanisms. Published data suggest that early removal of triglycerides (TGs) and toxic free fatty acids (FFAs) may be advantageous; however, high-quality evidence is still missing in the literature. Methods: /Design: ELEFANT is a randomized controlled, multicenter, international trial testing the concept that early elimination of TGs and FFAs from the blood is beneficial in HTG-AP. The study will be performed with the adaptive "drop-the-loser" design, which supports the possibility of dropping the inferior treatment arm, based on the results of the interim analysis. Patients with HTG-AP defined by TG level over 11.3 mmol/l (1000 mg/dL) are randomized into three groups: (A) patients who undergo plasmapheresis and receive aggressive fluid resuscita- tion; (B) patients who receive insulin and heparin treatment with aggressive fluid resuscitation; and (C) patients with aggressive fluid resuscitation. Please note that all intervention must be started within 48 h from the onset of abdominal pain. Exclusion criteria are designed logically to decrease the possibility of any distorting effects of other diseases. The composite primary endpoint will include both severity and mortality.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Acute pancreatitis Hypertriglyceridemia Plasmapheresis Free fatty acids Heparin Insulin Randomized clinical trial
Megjelenés:	Pancreatology. - 20 : 3 (2020), p. 369-376. -
További szerzők:	Gede Noémi Antal Judit Szentesi Andrea Alizadeh, Hussain Vincze Áron Izbéki Ferenc Papp Mária (1975-) (belgyógyász, gasztroenterológus) Czakó László Varga Márta de-Madaria, Enrique Petersen, Ole H. Singh, Vijay P. Mayerle, Julia Faluhelyi Nándor Miseta Attila Reiber István Hegyi Péter (pszichológus)
Pályázati támogatás:	GINOP-2.3.2-15-2016-00048 GINOP KH-125678 Egyéb EFOP-3.6.2-16-2017-00006 EFOP LP2014-10/2014 Egyéb
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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