Last reviewed · How we verify
NCT04767347: Aim1
Renal Considerations in the Heat Stress Recommendations
NA trial testing 23.0°C WBGT - Fixed Work Rate in Hot Weather; Adverse Effect in 38 participants. Completed in 4 May 2023.
4 May 2023
Quick facts
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 38 |
| Start date | 1 March 2021 |
| Primary completion | 4 May 2023 |
| Estimated completion | 4 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 23.0°C WBGT - Fixed Work Rate
- 25.5°C WBGT - Fixed Work Rate
- 27.5°C WBGT - Fixed Work Rate
- 28.5°C WBGT - Fixed Work Rate
- 35.5°C WBGT - Fixed Work Rate
- 26.0°C WBGT - Fixed work-to-rest ratio
- 30.5°C WBGT - Fixed work-to-rest ratio
- 30.5°C WBGT - Fixed work-to-rest ratio (high intensity)
Conditions studied
- Hot Weather; Adverse Effect — all drugs for Hot Weather; Adverse Effect →
- Kidney Dysfunction — all drugs for Kidney Dysfunction →
- Kidney Injury — all drugs for Kidney Injury →
- Hyperthermia — all drugs for Hyperthermia →
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):
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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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04767347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hot Weather; Adverse Effect
Currently open trials in the same condition.
- NCT06982339 — Beat the Heat Boston · NA · recruiting
Other Indiana University trials
Trials by the same sponsor.
- NCT07470086 — The Role of Environmental Temperatures in Respiratory Control · NA · not yet recruiting
- NCT07470099 — The Role of Breathing Perception in Respiratory Control · NA · not yet recruiting
- NCT07179952 — Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA ) · Phase 2 · not yet recruiting
- NCT07070804 — Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers · not yet recruiting
- NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04767347 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indiana University
- Last refreshed: 8 November 2023
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