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NCT04767347: Aim1

Renal Considerations in the Heat Stress Recommendations

Completed NA Last updated 8 November 2023
What this trial tests

NA trial testing 23.0°C WBGT - Fixed Work Rate in Hot Weather; Adverse Effect in 38 participants. Completed in 4 May 2023.

Timeline
1 March 2021
Primary endpoint
4 May 2023
4 May 2023

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment38
Start date1 March 2021
Primary completion4 May 2023
Estimated completion4 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

Adults 18 to 44, any sex, with Hot Weather; Adverse Effect or Kidney Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ad libitum drinking prevents dehydration during physical work in the heat when adhering to occupational heat stress recommendations.
    Hess HW, Tarr ML, Baker TB, Hostler D, et al · · 2022 · cited 10× · PMID 36211944 · DOI 10.1080/23328940.2022.2094160
  2. Occupational Heat Stress Recommendation Compliance Attenuates AKI Risk Compared with a Work-Rest Ratio-Matched, Positive Control Scenario.
    Hess HW, Baker TB, Tarr ML, Zoh RS, et al · · 2023 · cited 9× · PMID 37907448 · DOI 10.34067/kid.0000000000000288
  3. Creatinine clearance is maintained in a range of wet-bulb globe temperatures and work-rest ratios during simulated occupational heat stress.
    Hess HW, Baker TB, Tarr ML, Zoh RS, et al · · 2024 · cited 3× · PMID 38867674 · DOI 10.1152/ajprenal.00089.2024
  4. Influence of work intensity on acute kidney injury risk during simulated occupational heat stress.
    Hess HW, Heikkinen ME, Tourula E, Hite MJ, et al · · 2025 · cited 2× · PMID 39855252 · DOI 10.1152/japplphysiol.00590.2024
  5. Critical Assessment of the Recommended Alert Limit Curves for Occupational Heat Exposure.
    Hess HW, Hite MJ, Heikkinen ME, Tarr ML, et al · · 2025 · cited 1× · PMID 40914830 · DOI 10.1002/ajim.70022

Verify or expand the search:

Other recruiting trials for Hot Weather; Adverse Effect

Currently open trials in the same condition.

Other Indiana University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04767347.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing