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. 2024 Apr 29;25(1):288.
doi: 10.1186/s13063-024-08113-w.

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

Javier Ripollés-Melchor  1   2   3 , Laura Carrasco-Sánchez  4   5   6   7 , José L Tomé-Roca  4   8 , César Aldecoa  4   9 , Andres Zorrilla-Vaca  4   10 , Juan V Lorente-Olazábal  4   11 , María J Colomina  4   12 , Ana Pérez  4   13 , Juan I Jiménez-López  4   14 , Rosalía Navarro-Pérez  4   15 , Alfredo Abad-Gurumeta  16   17 , Manuel I Monge-García  4   18 ; HYT Study Group
Collaborators, Affiliations

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

Javier Ripollés-Melchor et al. Trials. .

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® 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: Acute Kidney Injury; Early oal-irected emodynamic therapy; Fluid herapy; Hemodynamic onitoring; Hemodynamic ptimization; Major lective bdominal urgery; Mortality; Postoperative omplications.

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Conflict of interest statement

JRM: Payments for conferences from Edwards Lifesciences and Fresenius Kabi, LC Payments for conferences from Edwards Lifesciences. JLTR Payments for conferences from Edwards Lifesciences and Braun. MIMG Payments for conferences from Edwards Lifesciences. JVLO: Payments for conferences from Edwards Lifesciences and Braun. AP Payments for conferences from Edwards Lifesciences. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Hemodynamic algorithm
See this image and copyright information in PMC

References

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    1. Ripollés-Melchor J, Ruiz-Escobar A, Fernández-Valdes-Bango P, et al. Hypotension prediction index: from reactive to predictive hemodynamic management, the key to maintaining hemodynamic stability. Front Anesthesiol. 2023. Available from: https://www.frontiersin.org/articles/ https://10.3389/fanes.2023.1138175. - DOI
    1. Wijnberge M, Geerts BF, Hol L, et al. Effect of a machine learning-derived early warning system for intraoperative hypotension vs standard care on depth and duration of intraoperative hypotension during elective noncardiac surgery: the HYPE randomized clinical trial. JAMA. 2020;323(11):1052–1060. doi: 10.1001/jama.2020.0592. - DOI - PMC - PubMed

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