The hypotension prediction index in major abdominal surgery – A prospective randomised clinical trial protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101417

Jakub Szrama, Agata Gradys, Zuzanna Nowak, Ashish Lohani, Krzysztof Zwoliński, Tomasz Bartkowiak, Amadeusz Woźniak, Tomasz Koszel, Krzysztof Kusza

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引用次数: 0

Abstract

Background

Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.

Methods

and Analysis: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of <65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.

Ethics and dissemination

This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB–559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT06247384.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.