학술논문

Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial
Document Type
Clinical report
Author
Ripollés-Melchor, JavierCarrasco-Sánchez, LauraTomé-Roca, José L.Aldecoa, CésarZorrilla-Vaca, AndresLorente-Olazábal, Juan V.Colomina, María J.Pérez, AnaJiménez-López, Juan I.Navarro-Pérez, RosalíaAbad-Gurumeta, AlfredoMonge-García, Manuel I.Ruiz-Escobar, AliciaFernánez-Valdes-Bango, PaulaEspinosa, Ãngel V.Pradera, María A. FuentesRueda, Azahara CortesAdell-Perez, Ana B.Agarrista-Aguirrezabala, IkerAmelburu-Egoscozabal, MartaAriéo-Larraéaga, Josude Haro-Ferrari, AitorEced-Sanchez, ManuelEizaguirre-Cotado, MariaEnparantza-Aiestaran, AlazneGarcia-Fernandez, CristinaGaricano-Goldaraz, CarmenGonzalez-Jorrin, NuriaGonzalez-Santos, SilviaLara-Jimenez, AndreaLodoso-Ochoa, EdurneLopetegui-Aizpurua, AmaiaMendoza-Sorrondegi, JorgeOsorio-Lopez, AntiaUria-Azpiazu, AmaiaZarcero, Virginia SerranoAbad-Motos, AneKhudair, Hussein AbuOjeda, Rocío VenturoliMingote-Lladó, AlvaroGutiérrez-Martínez, DiegoGutiérrez-Martínez, AlbertoMartín, Ana MorenoGarcía-Fernández, JavierTorres, Bartolomé Fernándezde Pablos, Ignacio MartinLourtau, Javier María ValienteEspinosa, Estefanía PeraltaGutiérrez, Jose Manuel PrietoPaniego, Víctor LamaDuque, Ãngel CárdenasBecerra-Bolaéos, ÃngelFocaccio-Tejada, Carmen A.Rodríguez-Pérez, AurelioLópez-Ruiz, SergioValencia-Sola, LucíaGalán-Menéndez, PatriciaGarcía-López, DanielSadurni-Sarda, MarcRivera-Ramos, HugoRomero-Bhathal, IreneCastelltort-Masco, LauraMoreno-Martinez, Carlos E.Carazo-Cordobes, JesusLarraéaga-Altuna, LeireBassas-Parga, EvaTejedor-Navarro, AnaFernanz-Antón, JesúsGarcia-Martínez, MartaCarmona-Blesa, AleixPujol-Rosa, ElisendaMoncho-Rodríguez, J. MiquelCueva-Castro, Luisa F.Batalla-González, Astrid M.Giné-Servén, MartaBastitta, María M.Pardo-Pinzón, Laura A.Arjona-Navarro, AlexAzparren-Cabezón, GonzaloGutiérrez-Marqués, AlejandroGarcía-Rodriguez, AlejandroPaz-Martín, AdrianoLladó-Jordan, GinaRábago-Moriyón, José L.Suárez-Castaéo, Ceferinade Eulate, Ana Bolado-ÃlvarezEscudero-Gómez, GabrielCastaéo-Ãlvarez, JuliaLarraz-Mármol, EduardoSancho-Carrancho, RodrigoAlonso-Fernández, MartaBarrio-Pérez, Irma M.González-Argüelles, NelMartínez-Ãlvarez, SaraReyes-Echeverría, Adriana I.Tejón-Pérez, GuillermoPascual-Casado, ÃngelaGarmilla-Ezquerra, Pablode la Vega, Angel Villar PellitGordillo, Santiago SecoMoreno, Ana M. QuinteroDomínguez, Peéa GómezMojarro, IreneGarcía, Jordi LlorcaPerea, Francisco J. CaéasLlimargas, Cristina PratJofré, Pere EsquiusMontesinos-Fadrique, SantiagoYanes, GabrielOcón-Moreno, AlvaroMoreno-Jiménez, SamuelQuevedo-Gutiérrez, AlbertoMedina-Martos, MiguelHerrera-Lozano, LauraMartín-Infantes, Sandra L.Palacios-Vega, Carlos M.Garcia-Bertini, Cesar P.Salinas-Moya, ÃngelaVenturoli, RocíoMoreno, AnaMuéoz, AdriánLobato, PabloMallol, MontserratGutierrez, AndreaGuillen, AntonioMugarra, AnaMonleón, BertaGimeno, AnaRomero, EstherPassariello, EduardoBeltran, CarmenRivas, EvaUbré, MartaTena, BeatrizComino, ÃscarDieguez, IagoEchevarria-Correas, Miren A.Chasco-Ganuza, MaiteOlvera-García, MercedesArrabal, AlejandoDíaz, MartaCaballero-Milan, MartaAlonso-Nadal, GuillermoPuig-Sanz, GuillermoNavarro-Garcia, Antonio-JoseCebria-Fondevila, MarcMillan-Ruiz, MíriamLi, WanyiSagartal, NeusDam, TatianaPuig, JaumeAlós-Zaragozá, L.Pallárdó-López, MA.Rosselló-Chornet, MartaMunoz-Devesa, L.Hernández-Cádiz, MJ.Hernández-Laforet, J.Sanchis, R.Biosca-Pérez, E.Fernández, Y.Vaquero, LauraLaguna, DavidDiaz, AlbaBordell, AliciaAguado, EstherVelasco, DeliaRuiz, EugenioGarcia-Matesanz, MaríaArranz, Irenede Leon, María Jesus SanzBlanco, Maria-JoseArias-Cuesta, GerardoAzzam-López, AmalMartín-González, María C.Ruíz-Torres, IsabelRacionero-González, PabloEscobar-Tapias, JimenaGonzalo-Millán, AlbaRemesal, Yolanda DiezGarrido, José L.Arnau-Bartés, AnnaReguant-Corominas, FrancescaDos-Santos-Carregal, Lauradel-Río, SabelaCurado-Zafra, GemaSaiz-Sánchez, PaolaPaniagua-Pacheco, IsabelMorales-Cubero, ÃngelaGarrido-Calmaestra, José L.Valbuena-Bueno, Miguel A.Pedregosa-Sanz, AnaAbreu-Paradell, SantiagoVallhonrat-Alcántara, PauAlonso-Manzano, AnnaPalma, CarolinaEsteban-Fernández, MartíNassar-Clavijo, LuisAlraqqab, AhmadAyesh, ZaidBarhoum, AbderrahmanAl-Kharabsheh, Murad
Source
Trials. April 29, 2024, Vol. 25 Issue 1
Subject
Company business management
Medical care, Cost of -- Health aspects
Mortality
Sensors -- Health aspects
Clinical trials -- Health aspects
Language
English
ISSN
1745-6215
Abstract
Background Acute kidney injury (AKI) is a significant postoperative complication associated with increased mortality and hospital costs. Hemodynamic strategies, such as goal-directed therapy, might reduce AKI risk. Predicting and proactively managing intraoperative hypotension may be helpful. This trial aims to investigate if a preemptive hemodynamic strategy guided by the hypotension prediction index (HPI) can decrease the incidence of moderate-to-severe AKI within 30 days following major elective abdominal surgery. Methods This is an open-label, controlled, multicenter, randomized clinical trial that involves daily patient follow-up until hospital discharge. Inclusion criteria are patients aged over 65 and/or categorized as ASA III or IV physical status, undergoing major elective abdominal surgery (general, urological, or gynecological procedures) via laparoscopic or open approach under general or combined anesthesia. Intervention In the intervention group, hemodynamic management will be based on the HPI and the advanced functional hemodynamic variables provided by the Hemosphere platform and the AcumenIQ[R] sensor (Edwards Lifesciences). The primary outcome is the incidence of moderate-to-severe AKI within 7 days post-surgery. Secondary outcomes include postoperative complications and 30-day mortality. Discussion This study explores the potential of HPI-guided hemodynamic management in reducing AKI after major elective abdominal surgery, with implications for postoperative outcomes and patient care. Trial registration ClinicalTrials.gov NCT05569265. Registered on October 6, 2022. Keywords: Hemodynamic ptimization, Major lective bdominal urgery, Early oal-irected emodynamic therapy, Fluid herapy, Hemodynamic onitoring, Postoperative omplications, Acute Kidney Injury, Mortality
Author(s): Javier Ripollés-Melchor[sup.1,2,3], Laura Carrasco-Sánchez[sup.2,4,5,6], José L. Tomé-Roca[sup.2,7], César Aldecoa[sup.2,8], Andres Zorrilla-Vaca[sup.2,9], Juan V. Lorente-Olazábal[sup.2,10], María J. Colomina[sup.2,11], Ana Pérez[sup.2,12], Juan I. Jiménez-López[sup.2,13], Rosalía Navarro-Pérez[sup.2,14], Alfredo Abad-Gurumeta[sup.1,3], Manuel I. Monge-García[sup.2,15], [...]