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Идёт набор NCT06247384

The Hypotension Prediction Index in Major Abdominal Surgery

Без фазы С лечением Hypotension During Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hypotension Prediction Index Hemodynamic Monitoring.
Кому может быть актуально
Состояния в реестре: Hypotension During Surgery. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.

Обзор

The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery. Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index. The main question the study aims to answer is: • will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.

Подробное описание

The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.

Вмешательства

  • Устройство Hypotension Prediction Index Hemodynamic Monitoring
    The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.

Первичные конечные точки

  • Time weighed average of hypotension below 65 mmHg [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
Вторичные конечные точки (10)
  • Time weighed average of hypotension below 50 mmHg [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
  • Time weighed average of hypertension above 90 mmHg [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
  • Time weighed average of hypertension above 100 mmHg [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
  • 30 day mortality [Срок оценки: 30 consecutive days starting from the day of the surgery]
  • Length of hospitalisation [Срок оценки: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days]
  • Myocardial injury evaluated by postoperative troponin levels [Срок оценки: First, second and fifth postoperative day]
  • Kidney injury evaluated by creatinine levels [Срок оценки: First, second and fifth postoperative day]
  • Intraoperative fluid dose [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
  • Intraoperative vasopressor dose [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
  • Rate of intra and postoperative atrial fibrillation [Срок оценки: "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]

Критерии участия

Критерии включения

  • Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of >15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
  • Patients with American Society of Anesthesiologists (ASA) status III or IV.
  • Written informed consent.

Критерии исключения

  • Patients under 18 years
  • Lack of health insurance
  • Pregnancy
  • Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
  • Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • Department of Anesthesiology, Intensive Therapy and Pain Management — Poznan

Публикации

  • Szrama J, Gradys A, Nowak Z, Lohani A, Zwolinski K, Bartkowiak T, Wozniak A, Koszel T, Kusza K. The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol. Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb. PMID 39895857

Идентификаторы

NCT: NCT06247384 · PoznanUMSHPI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗