Renal Considerations in the Heat Stress Recommendations (Aim2)

Not Applicable

Completed

• Conditions: Hot Weather; Adverse Effect; Kidney Dysfunction; Kidney Injury; Hyperthermia; Dehydration
• Interventions: Procedure: Fluid replacement; Procedure: No fluid replacement

• Registration Number: NCT05458843
• Lead Sponsor: Indiana University

Brief Summary

An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is largely unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration that elicit oxidative stress and inflammation in the renal tubules. The purpose of this study is to determine whether hydration status modifies the development of renal oxidative stress and inflammation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Study Start: 2022-08-01
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Men and women
• 18-44 y old
• Body mass index ≤35.0 kg/m2
• Self-reported to be healthy

Exclusion Criteria

• Not within defined age range
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
• Body mass index >35.0 kg/m2
• Current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery
• Hypertension during screening (systolic blood pressure >139 or diastolic blood pressure >89)
• Using medications that blunt the physiological response to exercise (e.g., beta blockers)
• Prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics)
• Positive pregnancy test at any time during the study or breast feeding
• Current tobacco or electronic cigarette use or consistent use within the last 2 years
• Answered "Yes" to any question on Page 1 of the PAR-Q+.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluid replacement	Fluid replacement	-
No fluid replacement	No fluid replacement	-

Primary Outcome Measures

Name	Time	Method
Peak urinary thioredoxin	Through study completion, up to twelve weeks	Marker of renal oxidative stress
Peak urinary MCP-1	Through study completion, up to twelve weeks	Marker of renal inflammation

Secondary Outcome Measures

Name	Time	Method
Peak urinary [IGFBP7 x TIMP-2]	Through study completion, up to twelve weeks	Kidney injury marker
Segmental artery blood velocity	Through study completion, up to twelve weeks	Measure of kidney blood flow
Renal artery blood velocity	Through study completion, up to twelve weeks	Measure of kidney blood flow

Trial Locations

Locations (1)

School of Public Health; 🇺🇸 Bloomington, Indiana, United States