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Renal Considerations in the Heat Stress Recommendations

Renal Considerations in the Heat Stress Recommendations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04767347
Acronym
Aim1
Enrollment
38
Registered
2021-02-23
Start date
2021-03-01
Completion date
2023-05-04
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Hot Weather; Adverse Effect, Hyperthermia, Kidney Dysfunction, Kidney Injury

Brief summary

An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. The current heat stress recommendations for workers were not developed with regards for kidney health. The purpose of this study is to determine if the current recommendations protect against kidney dysfunction.

Interventions

OTHER23.0°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions: 23.0°C WBGT (29°C, 46% relative humidity) @ 60 min exercise per hour

OTHER25.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions: 25.5°C WBGT (31°C, 52% relative humidity) @ 45 min exercise per hour

OTHER27.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions: 27.5°C WBGT (33°C, 53% relative humidity) @ 30 min exercise per hour

OTHER28.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions: 28.5°C WBGT (34°C, 54% relative humidity) @ 15 min exercise per hour

OTHER35.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions: 35.5°C WBGT (40°C, 65% relative humidity) @ 15 min exercise per hour

OTHER26.0°C WBGT - Fixed work-to-rest ratio

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour. 26.0°C WBGT (31°C, 55% relative humidity) @ 530 W metabolic heat production

OTHER30.5°C WBGT - Fixed work-to-rest ratio

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour. 30.5°C WBGT (36°C, 55% relative humidity) @ 230 W metabolic heat production

OTHER30.5°C WBGT - Fixed work-to-rest ratio (high intensity)

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour. 30.5°C WBGT (36°C, 55% relative humidity) @ 530 W metabolic heat production

Sponsors

State University of New York at Buffalo
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participant will not be directly informed of the experimental conditions and will be blinded to the hypotheses. The outcomes assessor will be blinded to the experimental conditions when analyzing the data.

Intervention model description

This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios during occupational heat stress on kidney function.

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women * 18-44 y old * Body mass index ≤35.0 kg/m2 * Self-reported to be healthy.

Exclusion criteria

* Not within defined age range * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 * Deemed highly active according to the physical activity questionnaire (i.e., \>3500 MET\*min/wk) * Body mass index \>35.0 kg/m2 * Current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery * Hypertension during screening (systolic blood pressure \>139 or diastolic blood pressure \>89) * Using medications that blunt the physiological response to exercise (e.g., beta blockers) * Prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics) * Positive pregnancy test at any time during the study or breast feeding * Current tobacco or electronic cigarette use or consistent use within the last 2 years * Inability to safely complete the peak oxygen uptake test

Design outcomes

Primary

MeasureTime frameDescription
Peak urinary [IGFBP7•TIMP-2]through study completion, up to 20 weeksKidney injury marker

Secondary

MeasureTime frameDescription
Urinary IGFBP7through study completion, up to 20 weeksKidney injury marker
Urinary TIMP-2through study completion, up to 20 weeksKidney injury marker
Urinary IL-18through study completion, up to 20 weeksKidney injury marker
Urinary NGALthrough study completion, up to 20 weeksKidney injury marker
Renal artery blood velocitythrough study completion, up to 20 weeksIndex of kidney blood flow
Segmental artery blood velocitythrough study completion, up to 20 weeksIndex of kidney blood flow
Urinary L-FABPthrough study completion, up to 20 weeksKidney injury marker

Other

MeasureTime frameDescription
Urine osmolalitythrough study completion, up to 20 weeksHydration status variable
Blood and plasma volumethrough study completion, up to 20 weeksHydration status variable
Urine specific gravitythrough study completion, up to 20 weeksHydration status variable
Plasma copeptinthrough study completion, up to 20 weeksHydration status variable
Whole-body sweat ratethrough study completion, up to 20 weeksHydration and heat strain variable
Fractional excretion of electrolytesthrough study completion, up to 20 weeksKidney function variable
Free water clearancethrough study completion, up to 20 weeksKidney function variable
Serum uric acidthrough study completion, up to 20 weeksKidney function variable
Urinary uric acidthrough study completion, up to 20 weeksKidney function variable
Creatinine clearancethrough study completion, up to 20 weeksKidney function variable
Core body temperaturethrough study completion, up to 20 weeksHeat strain variable
Mean skin temperaturethrough study completion, up to 20 weeksHeat strain variable
Oxygen uptakethrough study completion, up to 20 weeksHeat strain variable
Heart ratethrough study completion, up to 20 weeksHeat strain variable
Blood pressurethrough study completion, up to 20 weeksHeat strain variable
Percentage change in body weightthrough study completion, up to 20 weeksHydration status variable
Plasma osmolalitythrough study completion, up to 20 weeksHydration status variable

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026