Hemodynamic Management guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial
Authors: Ripollés-Melchor Javier , Tomé-Roca José L. , Zorrilla-Vaca Andrés , Aldecoa César , Colomina María J. , Bassas-Parga Eva , Lorente Juan V. , Ruiz-Escobar Alicia , Carrasco-Sánchez Laura , Sadurni-Sarda Marc , Rivas Eva , Puig Jaume , Agudelo-Montoya Elizabeth , Del Rio-Fernández Sabela , García-López Daniel , Adell-Pérez Ana B. , Guillen Antonio , Venturoli-Ojeda Rocío , Fernández-Torres Bartolomé , Abad-Motos Ane , Mojarro Irene , Garrido-Calmaestra José L. , Fernanz-Antón Jesús , Pedregosa-Sanz Ana , Cueva-Castro Luisa , Echevarria-Correas Miren A. , Mallol Montserrat , Olvera-García María M. , Navarro-Pérez Rosalía , Fernández-Valdés-Bango Paula , García-Fernández Javier , Espinosa Ángel V. , Abu Khudair Hussein , Becerra-Bolaños Ángel , Díez-Remesal Yolanda , Fuentes-Pradera María A. , Valbuena-Bueno Miguel A. , Quintana-Villamandos Begoña , Llorca-García Jordi , Fernández-López Ignacio , Ocón-Moreno Álvaro , Martín-Infantes Sandra L. , Valiente-Lourtau Javier M. , Amelburu-Egoscozabal Marta , Rivera-Ramos Hugo , Abad-Gurumeta Alfredo , Monge-García Manuel I. ,   on behalf of the HYT Study Group.
Published: January 2025

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.

ClinicalTrials.gov Identifier:

NCT05569265