NCT05302674

Brief Summary

The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

March 11, 2022

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in fatigue

    Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.

    Hour 4

  • Biomarkers of acute kidney injury

    Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury.

    Hour 4

Study Arms (1)

Hot Dry

EXPERIMENTAL

The participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment.

Other: Hot Dry

Interventions

Hot DryOTHER

98°F (36.7°C) and 20% relative humidity environment

Hot Dry

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Regularly completes aerobic exercise at least 60 min per week

You may not qualify if:

  • History of cardiovascular, metabolic, respiratory, neural, or renal disease
  • Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure \> 139 mmHg, Diastolic Blood Pressure \> 89 mmHg, heart rate \> 100 bpm)
  • Current tobacco or nicotine use or previous regular use within the past 2 years
  • Current or previous musculoskeletal injury limiting physical activity
  • Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
  • A positive pregnancy test at any point during the study or currently breastfeeding
  • Study physician discretion based on any other medical condition or medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research and Education in Special Environments

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Heat Stress DisordersFatigue

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Riana R Pryor, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 31, 2022

Study Start

April 1, 2022

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to share individual participant data with other researchers. Aggregate results will be shared via publications and/or presentations.

Locations