Renal Considerations in the Heat Stress Recommendations

Not Applicable

Completed

• Conditions: Hot Weather; Adverse Effect; Dehydration; Kidney Injury; Kidney Dysfunction; Hyperthermia

• Registration Number: NCT04767347
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak urinary [IGFBP7•TIMP-2]	through study completion, up to 20 weeks	Kidney injury marker

Secondary Outcome Measures

Name	Time	Method
Urinary IL-18	through study completion, up to 20 weeks	Kidney injury marker
Urinary NGAL	through study completion, up to 20 weeks	Kidney injury marker
Urinary TIMP-2	through study completion, up to 20 weeks	Kidney injury marker
Renal artery blood velocity	through study completion, up to 20 weeks	Index of kidney blood flow
Urinary L-FABP	through study completion, up to 20 weeks	Kidney injury marker
Urinary IGFBP7	through study completion, up to 20 weeks	Kidney injury marker
Segmental artery blood velocity	through study completion, up to 20 weeks	Index of kidney blood flow

Trial Locations

Locations (1)

School of Public Health; 🇺🇸 Bloomington, Indiana, United States