Heat Waves and the Elderly - Cooling Modalities
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: Water Spray, Fan, Water Spray and Fan, Control.
- Кому может быть актуально
- Состояния в реестре: Aging, Hyperthermia. Базовые параметры: от 65 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
Обзор
The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions
Подробное описание
Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Such deaths are primarily cardiovascular, not hyperthermia itself, in origin. The central hypothesis of this work is that cardiovascular stress during heat wave conditions in the elderly can be reduced by applying low-energy cooling modalities. Comprehensive cardiovascular and thermal responses in the elderly will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave), very hot and dry (replicating the 2018 Los Angeles heat wave). With each of these heat wave conditions individuals will be exposed to the following cooling modalities: no cooling (control), water spray, fan use, and fan use plus water spray.
Вмешательства
- Другое Water Spray
Participants will receive water spraying on their body throughout the climate chamber exposure. - Другое Fan
Participants will be exposed to a fan throughout the climate chamber exposure. - Другое Water Spray and Fan
Participants will receive both water spraying and a fan throughout the climate chamber exposure. - Другое Control
Participants will NOT receive either water spray or a fan exposure.
Первичные конечные точки
- Change in core body temperature [Срок оценки: Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.]
- Change in left ventricular function [Срок оценки: Within 60 minutes before each simulated heat wave exposure, around minute 90 of the heat wave exposure, and at the end of the 3 hour heat wave exposure]
Вторичные конечные точки (12)
- Heart rate [Срок оценки: Prior to and throughout each simulated heat wave exposure; approximately 420 minutes]
- Cardiac output [Срок оценки: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- Arterial blood pressure [Срок оценки: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes]
- Whole body sweat rate [Срок оценки: Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.]
- Markers of renal function and injury - Cystatin C [Срок оценки: Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure]
- Markers of renal function and injury - Creatinine Clearance [Срок оценки: Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure]
- Markers of renal function and injury - Insulin-like growth factor-binding protein 7 [Срок оценки: Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure]
- Markers of renal function and injury - Tissue inhibitor of metalloproteinases 2 [Срок оценки: Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure]
- Cerebral perfusion [Срок оценки: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- High sensitive cardiac troponin [Срок оценки: Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure]
- Skin temperature [Срок оценки: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- Forced vital capacity (FVC) [Срок оценки: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
Критерии участия
Критерии включения
- 65 years of age or older
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Критерии исключения
- Known heart disease
- Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc;
- Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Subject with a body mass index ≥31 kg/m2
- Pregnant individuals
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Texas Health Presbyterian Hospital Dallas — Dallas
Идентификаторы
NCT: NCT05484739 · STU-2022-0625