Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

NCT05710978 | Withdrawn

• 1 other identifier: STUDY00005847-Pilot
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Hyperthermia; Kidney Injury, Acute

Outcome Measures

Primary Outcomes (3)

• [TIMP-2 x IGFBP-7] concentration

  The product of \[Tissue inhibitor of metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP7)\] is a biomarker that has the potential for prediction of acute kidney injury.

  Minute 0

• [TIMP-2 x IGFBP-7] concentration

  The product of \[Tissue inhibitor of metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP7)\] is a biomarker that has the potential for prediction of acute kidney injury.

  Hour 4

• [TIMP-2 x IGFBP-7] concentration

  The product of \[Tissue inhibitor of metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP7)\] is a biomarker that has the potential for prediction of acute kidney injury.

  Hour 5

Secondary Outcomes (9)

• NGAL concentration

  Minute 0

• NGAL concentration

  Hour 4

• NGAL concentration

  Hour 5

• Serum creatinine concentration

  Minute 0

• Serum creatinine concentration

  Hour 4

Study Arms (1)

Work Heat Stress

EXPERIMENTAL

Each participant will complete three consecutive days of heavy intensity aerobic work in a hot environment.

Other: Work Protocol

Interventions

Work Protocol OTHER

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

Work Heat Stress

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals (18-39 years old)
• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Center for Research and Education in Special Environments

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Hyperthermia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Riana R Pryor, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 2, 2023
• Study Start: October 13, 2022
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)