Hemodynamic Management guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial.

Autor: Ripollés-Melchor J; Infanta Leonor University Hospital, Madrid, Spain.; Universidad Complutense de Madrid, Madrid, Spain.; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain., Tomé-Roca JL; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Virgen de las Nieves University Hospital, Granada, Spain., Zorrilla-Vaca A; Brigham and Women's Hospital, Boston, USA., Aldecoa C; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Río Hortega University Hospital, Valladolid, Spain., Colomina MJ; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Bellvitge University Hospital, Barcelona, Spain.; Barcelona University, Barcelona, Spain., Bassas-Parga E; Moisès Broggi University Hospital, Sant Joan Despí, Spain., Lorente JV; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Juan Ramón Jiménez University Hospital, Huelva, Spain., Ruiz-Escobar A; Infanta Leonor University Hospital, Madrid, Spain.; Universidad Complutense de Madrid, Madrid, Spain., Carrasco-Sánchez L; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain.; Doctoral Program in Medicine and Biomedical Sciences, University of Vic-Central University of Catalonia (UVic-UCC), Vic, Spain.; Institute of Research and Innovation in Life and Health Sciences in Central Catalonia (IRIS-CC), Vic, Spain., Sadurni-Sarda M; Del Mar University Hospital, Barcelona, Spain., Rivas E; Barcelona Clinic Hospital, Barcelona, Spain., Puig J; University General Hospital Consortium of Valencia, Valencia, Spain.; Valencia University, Valencia, Spain., Agudelo-Montoya E; University Hospital Complex of Badajoz, Badajoz, Spain., Del Rio-Fernández S; University Hospital Complex of Santiago, Santiago de Compostela, Spain., García-López D; Marqués de Valdecilla University Hospital, Santander, Spain., Adell-Pérez AB; Donostia University Hospital, San Sebastian, Spain., Guillen A; University Clinical Hospital of Valencia, Valencia, Spain., Venturoli-Ojeda R; Jerez de la Frontera University Hospital, Jerez de la Frontera, Spain., Fernández-Torres B; Virgen de la Macarena University Hospital, Sevilla, Spain., Abad-Motos A; Donostia University Hospital, San Sebastian, Spain., Mojarro I; Juan Ramón Jiménez University Hospital, Huelva, Spain., Garrido-Calmaestra JL; Reina Sofía University Hospital, Córdoba, Spain., Fernanz-Antón J; Moisès Broggi University Hospital, Sant Joan Despí, Spain., Pedregosa-Sanz A; Igualada University Hospital, Igualada, Spain., Cueva-Castro L; Sant Pau University Hospital, Barcelona, Spain., Echevarria-Correas MA; Basurto University Hospital, Bilbao, Spain., Mallol M; Barcelona University, Barcelona, Spain., Olvera-García MM; San Cecilio University Hospital, Granada, Spain., Navarro-Pérez R; Clínico San Carlos University Hospital, Madrid, Spain., Fernández-Valdés-Bango P; Infanta Leonor University Hospital, Madrid, Spain.; Universidad Complutense de Madrid, Madrid, Spain., García-Fernández J; Puerta de Hierro University Hospital, Majadahonda, Spain.; Autonomous University of Madrid, Madrid, Spain., Espinosa ÁV; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; King Salman Specialist Hospital, Hail, Kingdom of Saudi Arabia., Abu Khudair H; King Hussein Cancer Center, Amman, Jordan., Becerra-Bolaños Á; Doctor Negrín University Hospital of Gran Canaria, Gran Canaria, Spain., Díez-Remesal Y; Ramón y Cajal University Hospital, Madrid, Spain., Fuentes-Pradera MA; Virgen del Rocío University Hospital, Sevilla, Spain., Valbuena-Bueno MA; Polytechnic University of Madrid, Madrid, Spain.; Parc Taulí Research and Innovation Institute (I3PT), Sabadell, Spain., Quintana-Villamandos B; Universidad Complutense de Madrid, Madrid, Spain.; Gregorio Marañón University Hospital, Madrid, Spain., Llorca-García J; Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain., Fernández-López I; Gregorio Marañón University Hospital, Madrid, Spain., Ocón-Moreno Á; Virgen de las Nieves University Hospital, Granada, Spain., Martín-Infantes SL; Virgen de las Nieves University Hospital, Granada, Spain., Valiente-Lourtau JM; Virgen de la Macarena University Hospital, Sevilla, Spain., Amelburu-Egoscozabal M; Donostia University Hospital, San Sebastian, Spain., Rivera-Ramos H; Del Mar University Hospital, Barcelona, Spain., Abad-Gurumeta A; Infanta Leonor University Hospital, Madrid, Spain.; Universidad Complutense de Madrid, Madrid, Spain., Monge-García MI; Fluid Therapy and Hemodynamic Monitoring, Spanish Society of Anesthesia and Critical Care (SEDAR), Madrid, Spain.; Jerez de la Frontera University Hospital, Jerez de la Frontera, Spain.
Jazyk: angličtina
Zdroj: Anesthesiology [Anesthesiology] 2025 Jan 02. Date of Electronic Publication: 2025 Jan 02.
DOI: 10.1097/ALN.0000000000005355
Abstrakt: Background: Postoperative acute kidney injury (AKI) after major abdominal surgery leads to poor outcomes. The Hypotension Prediction Index (HPI) may aid in managing intraoperative hemodynamic instability. This study assessed if HPI-guided therapy reduces moderate-to-severe AKI incidence in moderate-to-high-risk elective abdominal surgery patients.
Methods: This multicenter randomized trial was conducted from October 2022 to February 2024 across 28 hospitals evaluating HPI-guided management compared to a wide range of real-world hemodynamic approaches. 917 patients (≥65 years or >18 years with ASA status >II) undergoing moderate-to-high-risk elective abdominal surgery were included in the intention-to-treat analysis. HPI-guided management triggered interventions when the HPI exceeded 80, using fluids and/or vasopressors/inotropes based on hemodynamic data. The primary outcome was the incidence of moderate-to-severe AKI within the first 7 days after surgery. Secondary outcomes included overall complications, the need for renal replacement therapy, duration of hospital stay, and 30-day mortality.
Results: Median age was 71 years (IQR, 65-77) in the HPI group and 70 years (IQR, 63-76) in standard care group. ASA status III/IV was 58.3% (268/459) in the HPI group and 57.9% (263/458) in standard care group. The incidence of moderate-to-severe AKI was 6.1% (28/459) in the HPI group and 7.0% (32/458) in the standard care group (RR 0.89, 95% 0.54-1.49; P=0.66). Overall complications occurred in 31.9% (146/459) of the HPI group and 29.7% (136/458) of the standard care group (RR 1.08, 95% CI 0.85-1.37; P = 0.52). The incidence of renal replacement therapy did not differ between groups. Median length of hospital stay was 6 days (IQR, 4-10) in both groups. The 30-day mortality was 1.1% (5/459) in the HPI group versus 0.9% (4/458) in standard care group (RR 1.35, 95% CI 0.36-5.10; P = 0.66).
Conclusions: HPI-guided hemodynamic therapy did not reduce the incidence of postoperative AKI or overall complications compared to standard care.
Clinicaltrialsgov Identifier: NCT05569265.
Competing Interests: Conflicts of Interest: Dr Ripollés-Melchor reports personal fees from Edwards Lifesciences, Bazter and Fresenius Kabi outside the submitted work. Dra. Colomina reports personal fees from Octapharma AG (Lachen, Switzerland), Fresenius Kabi España and CSL Vifor España, S.L. outside the submitted work. Dr .Lorente reports personal fees from Edwards Lifesciences, bioMérieux. Fresenius Kabi, Grifols, Vifor Pharma and Baxter outside the submitted work. Dr. Carrasco-Sánchez reports personal fees from Edwards Lifesciences outside the submitted work. Dr. Navarro-Pérez reports personal fees from Edwards Lifesciences outside the submitted work. Dr. Navarro-Pérez reports personal fees from Edwards Lifesciences outside the submitted work. Dr. Pedregosa-Sanz reports personal fees from Edwards Lifesciences outside the submitted work. Dr. Monge-García reports personal fees from Edwards Lifesciences outside the submitted work. The other authors declare no competing interests.
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Databáze: MEDLINE