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
Authors: Ripollés-Melchor Javier , Carrasco-Sánchez Laura , Tomé-Roca José L. , Aldecoa César , Zorrilla-Vaca Andres , Lorente-Olazábal Juan V. , Colomina María J. , Pérez Ana , Jiménez-López Juan I. , Navarro-Pérez Rosalía , Abad-Gurumeta Alfredo , Monge-García Manuel I. ,   the HYT Study Group, Ruiz-Escobar Alicia , Fernánez-Valdes-Bango Paula , Espinosa Ángel V. , Pradera María A. Fuentes , Rueda Azahara Cortes , Adell-Perez Ana B. , Agarrista-Aguirrezabala Iker , Amelburu-Egoscozabal Marta , Ariño-Larrañaga Josu , de Haro-Ferrari Aitor , Eced-Sanchez Manuel , Eizaguirre-Cotado Maria , Enparantza-Aiestaran Alazne , Garcia-Fernandez Cristina , Garicano-Goldaraz Carmen , Gonzalez-Jorrin Nuria , Gonzalez-Santos Silvia , Lara-Jimenez Andrea , Lodoso-Ochoa Edurne , Lopetegui-Aizpurua Amaia , Mendoza-Sorrondegi Jorge , Osorio-Lopez Antia , Uria-Azpiazu Amaia , Zarcero Virginia Serrano , Abad-Motos Ane , Khudair Hussein Abu , Ojeda Rocío Venturoli , Mingote-Lladó Alvaro , Gutiérrez-Martínez Diego , Gutiérrez-Martínez Alberto , Martín Ana Moreno , García-Fernández Javier , Torres Bartolomé Fernández , de Pablos Ignacio Martin , Lourtau Javier María Valiente , Espinosa Estefanía Peralta , Gutiérrez Jose Manuel Prieto , Paniego Víctor Lama , Duque Ángel Cárdenas , Becerra-Bolaños Ángel , Focaccio-Tejada Carmen A. , Rodríguez-Pérez Aurelio , López-Ruiz Sergio , Valencia-Sola Lucía , Galán-Menéndez Patricia , García-López Daniel , Sadurni-Sarda Marc , Rivera-Ramos Hugo , Romero-Bhathal Irene , Castelltort-Masco Laura , Moreno-Martinez Carlos E. , Carazo-Cordobes Jesus , Larrañaga-Altuna Leire , Bassas-Parga Eva , Tejedor-Navarro Ana , Fernanz-Antón Jesús , Garcia-Martínez Marta , Carmona-Blesa Aleix , Pujol-Rosa Elisenda , Moncho-Rodríguez J. Miquel , Cueva-Castro Luisa F. , Batalla-González Astrid M. , Giné-Servén Marta , Bastitta María M. , Pardo-Pinzón Laura A. , Arjona-Navarro Alex , Azparren-Cabezón Gonzalo , Gutiérrez-Marqués Alejandro , García-Rodriguez Alejandro , Paz-Martín Adriano , García-López Daniel , Lladó-Jordan Gina , Rábago-Moriyón José L. , Suárez-Castaño Ceferina , de Eulate Ana Bolado-Álvarez , Escudero-Gómez Gabriel , Castaño-Álvarez Julia , Larraz-Mármol Eduardo , Sancho-Carrancho Rodrigo , Alonso-Fernández Marta , Barrio-Pérez Irma M. , González-Argüelles Nel , Martínez-Álvarez Sara , Reyes-Echeverría Adriana I. , Tejón-Pérez Guillermo , Pascual-Casado Ángela , Garmilla-Ezquerra Pablo , de la Vega Angel Villar Pellit , Gordillo Santiago Seco , Moreno Ana M. Quintero , Domínguez Peña Gómez , Mojarro Irene , García Jordi Llorca , Perea Francisco J. Cañas , Llimargas Cristina Prat , Jofré Pere Esquius , Montesinos-Fadrique Santiago , Yanes Gabriel , Ocón-Moreno Alvaro , Moreno-Jiménez Samuel , Quevedo-Gutiérrez Alberto , Medina-Martos Miguel , Herrera-Lozano Laura , Martín-Infantes Sandra L. , Palacios-Vega Carlos M. , Garcia-Bertini Cesar P. , Salinas-Moya Ángela , Venturoli Rocío , Moreno Ana , Muñoz Adrián , Lobato Pablo , Mallol Montserrat , Gutierrez Andrea , Guillen Antonio , Mugarra Ana , Monleón Berta , Gimeno Ana , Romero Esther , Passariello Eduardo , Beltran Carmen , Rivas Eva , Ubré Marta , Tena Beatriz , Comino Óscar , Dieguez Iago , Echevarria-Correas Miren A. , Chasco-Ganuza Maite , Olvera-García Mercedes , Arrabal Alejando , Díaz Marta , Caballero-Milan Marta , Alonso-Nadal Guillermo , Puig-Sanz Guillermo , Navarro-Garcia Antonio-Jose , Cebria-Fondevila Marc , Millan-Ruiz Míriam , Li Wanyi , Sagartal Neus , Dam Tatiana , Puig Jaume , Alós-Zaragozá L. , Pallárdó-López MA. , Rosselló-Chornet Marta , Munoz-Devesa L. , Hernández-Cádiz MJ. , Hernández-Laforet J. , Sanchis R. , Martin  , Biosca-Pérez E. , Fernández Y. , Vaquero Laura , Laguna David , Diaz Alba , Bordell Alicia , Aguado Esther , Velasco Delia , Ruiz Eugenio , Garcia-Matesanz María , Arranz Irene , de Leon María Jesus Sanz , Blanco Maria-Jose , Arias-Cuesta Gerardo , Azzam-López Amal , Martín-González María C. , Ruíz-Torres Isabel , Racionero-González Pablo , Escobar-Tapias Jimena , Gonzalo-Millán Alba , Remesal Yolanda Diez , Garrido José L. , Arnau-Bartés Anna , Reguant-Corominas Francesca , Dos-Santos-Carregal Laura , del-Río Sabela , Curado-Zafra Gema , Saiz-Sánchez Paola , Paniagua-Pacheco Isabel , Morales-Cubero Ángela , Garrido-Calmaestra José L. , Valbuena-Bueno Miguel A. , Pedregosa-Sanz Ana , Abreu-Paradell Santiago , Vallhonrat-Alcántara Pau , Alonso-Manzano Anna , Palma Carolina , Esteban-Fernández Martí , Nassar-Clavijo Luis , Alraqqab Ahmad , Ayesh Zaid , Khudair Hussein Abu , Barhoum Abderrahman , Al-Kharabsheh Murad 
Published: April 2024

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® 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.