NCT05710978

Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

Withdrawn NA Last updated 13 November 2023

What this trial tests

NA trial testing Work Protocol in Hyperthermia. Withdrawn.

Timeline

13 October 2022

Primary endpoint
8 November 2023

8 November 2023

Quick facts

Lead sponsor	State University of New York at Buffalo
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Start date	13 October 2022
Primary completion	8 November 2023
Estimated completion	8 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Work Protocol

Conditions studied

• Hyperthermia — all drugs for Hyperthermia →
• Kidney Injury, Acute — all drugs for Kidney Injury, Acute →

Sponsor

State University of New York at Buffalo

Who can join

Adults 18 to 39, any sex, with Hyperthermia or Kidney Injury, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.