Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05710978

Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
State University of New York at Buffalo · Academic / Other
Sex
All
Age
18 Years – 39 Years
Healthy volunteers
Accepted

Summary

Prolonged, high intensity work in a hot environment results in significant strain on the body, known as heat strain. Heat strain in hot occupational settings such as agriculture, fire suppression, and military work can lead to \~20% of workers exceeding the glomerular filtration rate indicated thresholds for acute kidney injury (AKI). However, it is unclear whether these individuals truly experienced AKI or if these were normal, healthy physiologic responses. To better determine if AKI occurs in the staggering number of workers previously reported, AKI biomarkers are needed in addition to kidney function markers (e.g., glomerular filtration rate) to characterize this response. The product of urinary tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) is a promising Food and Drug Administration approved biomarker indicating risk of AKI and is currently used in hospitalized individuals. The usefulness of this biomarker in determining AKI in healthy individuals during heat strain is now beginning to be understood. Consecutive days of heat strain can result in repeated AKI, which is hypothesized to lead to chronic kidney disease. There is an epidemic of chronic kidney disease of non-traditional causes occurring in workers who undergo repeated days heat strain, including approximately 15% of outdoor workers in Central America. Of the few studies that investigated consecutive days of work in the heat, we demonstrated that participants exceed the glomerular filtration rate indicated threshold for AKI during consecutive days of heat strain. This project will determine whether \[TIMP-2 x IGFBP7\] increases during occupational relevant heat exposures in a healthy, active population. Additionally, this project will compare the impact of repeated exposures to a hot environment on risk of AKI.

Conditions

Interventions

TypeNameDescription
OTHERWork ProtocolParticipants will complete 4 hours of walking and cycling to a work:rest ratio of 3:1.

Timeline

Start date
2022-10-13
Primary completion
2023-11-08
Completion
2023-11-08
First posted
2023-02-02
Last updated
2023-11-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05710978. Inclusion in this directory is not an endorsement.