Heat Waves and the Elderly - Cooling Modalities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Water Spray, Fan, Water Spray and Fan, Control.
- Who it may be relevant to
- Registry conditions: Aging, Hyperthermia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
Overview
The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions
Detailed description
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.
Interventions
- Other Water Spray
Participants will receive water spraying on their body throughout the climate chamber exposure. - Other Fan
Participants will be exposed to a fan throughout the climate chamber exposure. - Other Water Spray and Fan
Participants will receive both water spraying and a fan throughout the climate chamber exposure. - Other Control
Participants will NOT receive either water spray or a fan exposure.
Primary outcome measures
- Change in core body temperature [Time frame: 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 [Time frame: 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]
Secondary outcome measures (12)
- Heart rate [Time frame: Prior to and throughout each simulated heat wave exposure; approximately 420 minutes]
- Cardiac output [Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- Arterial blood pressure [Time frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes]
- Whole body sweat rate [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- High sensitive cardiac troponin [Time frame: 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 [Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
- Forced vital capacity (FVC) [Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)]
Eligibility criteria
Inclusion criteria
- 65 years of age or older
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Texas Health Presbyterian Hospital Dallas — Dallas
Identifiers
NCT: NCT05484739 · STU-2022-0625