Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

Hyperthermia Clinical Trial

Official title:

Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05710978
• Other study ID #: STUDY00005847-Pilot
• Status: Withdrawn
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Healthy individuals (18-39 years old)

• Regularly completes aerobic exercise at least 60 min per week

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hyperthermia
• Kidney Injury, Acute
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Center for Research and Education in Special Environments	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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
Primary	[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
Primary	[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	NGAL concentration	Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.	Minute 0
Secondary	NGAL concentration	Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.	Hour 4
Secondary	NGAL concentration	Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.	Hour 5
Secondary	Serum creatinine concentration	Serum creatinine concentration is a measure of kidney function.	Minute 0
Secondary	Serum creatinine concentration	Serum creatinine concentration is a measure of kidney function.	Hour 4
Secondary	Serum creatinine concentration	Serum creatinine concentration is a measure of kidney function.	Hour 5
Secondary	Urine creatinine concentration	Urine creatinine concentration is a measure of kidney function.	Minute 0
Secondary	Urine creatinine concentration	Urine creatinine concentration is a measure of kidney function.	Hour 4
Secondary	Urine creatinine concentration	Urine creatinine concentration is a measure of kidney function.	Hour 5