Acute Kidney Injury and Ultra-endurance Running

NCT07519408 | Not Yet Recruiting

• 1 other identifier: IHPL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to understand how participating in the Western States Endurance Run (WSER), a 100-mile ultramarathon, affects kidney health. Long, strenuous exercise in hot conditions can temporarily strain the kidneys, especially when combined with dehydration, muscle breakdown, and the use of common pain-relief medications such as ibuprofen. Although kidney stress has been reported in endurance sports, no study has examined it directly in runners during the WSER using newer, more sensitive urine markers of kidney injury. Runners who volunteer will complete brief assessments before and after the race. These include providing a urine sample, a small finger-prick blood sample, a body-weight measurement, and answering a short questionnaire about pain-medication use. During the race, participants will wear a global positioning system (GPS) watch and heart-rate strap to monitor effort. Each assessment takes about 15 minutes, and no follow-up is required. Findings from this study will help determine how often kidney stress occurs in this event and what factors may contribute to it, ultimately supporting safer training and medical practices for ultramarathon athletes.

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Keywords

ultra-endurance; bicarbonate; AKI

Outcome Measures

Primary Outcomes (1)

• Insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinase 2 (TIMP-2), and neutrophil gelatinase-associated lipocalin (NGAL)

  urine biomarkers of acute kidney injury

  one hour prior to starting the race (baseline), immediately upon finishing the race (immediately post-race) and 24 from hours from the immediately post-race sample

Study Arms (2)

sodium bicarbonate

EXPERIMENTAL

volunteers will be provided 0.3g/kg body weight of sodium bicarbonate to be consumed after completing the Western States Endurance Run (100 miles)

Dietary Supplement: Sodium Bicarbonate (NaHCO3)

placebo

PLACEBO COMPARATOR

volunteers will be provide 0.3g/kg body weight of placebo (corn starch) to be consumed after the race.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

The placebo product consists of the same sodium concentration as the intervention group receiving sodium bicarbonate.

placebo

Sodium Bicarbonate (NaHCO3) DIETARY_SUPPLEMENT

SB will be used to investigate whether adding a buffer exogenously to aid recovery helps in reducing the severity of acute kidney injury.

sodium bicarbonate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Running in the Western States Endurance Run in either 2026, 2027 or 2028
• No contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) as prepared by the American College of Sports Medicine (ACSM)
• Not currently taking medicine or experiencing illness that may influence the cardiovascular or neuromuscular system
• Age ≥18 and ≤ 50 years old and injury free (skeletal muscle) for \> 3 months

You may not qualify if:

• Minors (under 18)
• Adults who are unable to consent (impaired decision-making capacity)
• Prisoners
• Pregnant Women
• Individuals with known kidney disease, or are on any medication that specifically effects kidney function (e.g., diuretics)

Sponsors & Collaborators

• Western States Endurance Run Research Foundation: collaborator
• Arizona State University: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 9, 2026
• Study Start (Estimated): June 27, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share