AKI (Acute Kidney Injury) Due to TraumaNCT07519408
Acute Kidney Injury and Ultra-endurance Running
A study testing Sodium Bicarbonate (NaHCO3) in people with AKI (Acute Kidney Injury) Due to Trauma, run by Arizona State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- AKI (Acute Kidney Injury) Due to Trauma
- What is being tested?
- Sodium Bicarbonate (NaHCO3)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: The Incidence and Severity of Acute Kidney Injury in Ultrarunners Competing in the Western States Endurance Run
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.
Read the detailed description
The study is a single-group, pre- and post-test design where participants will be assessed prior to the start of the WSER, upon completion of the race and 24 hours post-race. Approximately one hour prior to the race commencing, participants will be asked to void the entire contents of their bladder in a urine container in order to measure urine volume, flow rate and urine specific gravity (USG) to assess hydration status and for subsequent analysis of acute kidney injury (AKI) risk (insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinase 2 (TIMP-2), and neutrophil gelatinase-associated lipocalin (NGAL)). Participants will also be provided a Garmin 945 GPS watch and a wearable device (i.e., the HRM-PRO Run Dynamics strap) for the race. The system is a waterproof heartrate monitor strap with an embedded accelerometer that quantifies gait metrics (ground reaction force). At this time they will also have their weight measured, and complete a short questionnaire to document any recent intake of non-steroidal anti-inflammatory (NSAIDS) medication. Lastly, the research team will collect a small capillary sample (~ 300 microliters) of whole blood into a heparinised tube and immediately analyse the sample for creatinine (CR) and blood urea nitrogen (BUN) using a portable, point of care analyzer (i-STAT 1 Wireless, Abbott, Princeton).
Upon completing the WSER, participants will again be asked to provide a urine sample (following the pre-race methodology), have their weight measured, complete the questionnaire regarding additional NSAID use during the race, and lastly a final capillary blood sample for post-race analysis of CR and BUN. Participants will then be randomized into one of two groups (sodium bicarbonate (SB) or placebo), with one receiving a pre-packaged standard amount of either 15, 19, or 22 grams of sodium bicarbonate provided by Maurten (Maurten Bicarb System, MaurtenTM, Göteborg, SWE) depending on their body weight. MaurtenTM will also provide an equivalent placebo product. Participants will be asked to consume the SB or placebo, which is delivered in a patented hydrogel system (similar to a yogurt). The urine and blood sampling procedure will be repeated 24 hours post-race at a location to be determined.
All urine samples will be packed in an appropriately labeled biohazard container with cold packs, and brought back to the Arizona State University's Integrated Human Performance Lab (IHPL; Principle Investigator (PI)-Siegler) for measures of AKI risk with the research team. As per the Transportation Security Administration (TSA) regulations, biological specimens that are non-infectious and contain less than 30 mL of fluid in each container are permissible in checked baggage. The samples from each of the 3 races will be approximately 5 milliliters (mL) each subject (so estimated at 50 mL total for each of the 3 races).
Methodological Techniques \& Measurements:
Anthropometric Assessments (Descriptive Data) Participants will be asked to use the restroom to empty their bladder (this sample will be used for AKI biomarkers, urine volume and USG), after which measurements of height and body mass will be obtained. This measurement will occur pre- and post-race to estimate loss of body weight (e.g., dehydration).
Urine Volume and Specific Gravity (USG) Participants will be asked to void into graduated measuring containers (~ 900 mL), which will subsequently be used to calculate total urine volume pre-, post-race, and 24 hours post-race and normalize AKI markers. Once volume is obtained, samples from this measurement will be used to assess dehydration (USG) and for subsequent analysis of AKI (see Kidney Injury Markers). USG will be measured using a handheld refractometer (Atago PALTMSeries, Tokyo, JP).
Capillary Blood Draws Capillary blood (~ 300 microliters; 600 total) will be obtained from an index finger pre-, post-race and 24 hours post-race to measure creatinine (CR) and blood urea nitrogen (BUN) using a portable, point of care analyzer (i-STAT 1 Wireless, Abbott, Princeton).
Kidney Injury Markers AKI risk will be assessed using Enzyme-Linked Immunosorbent Assay (ELISA) kits to measure concentrations of insulin-like growth factor-binding protein 7 (IGFBP7) (RayBiotech Life, Peachtree Corners, GA), tissue inhibitor of metalloproteinase 2 (TIMP-2) (RayBiotech Life, Peachtree Corners, GA), and neutrophil gelatinase-associated lipocalin (NGAL) (Enzo Life Sciences, Farmingdale, NY). Urine samples will be centrifuged before analysis and resultant supernatant used for analyses. The kidney markers will be normalized to urine flow rate, considering changes in the urine production that may happen in dehydration conditions such as exercise in the heat. All ELISA analyses will be completed according to manufacturer guidelines.
Heart Rate and Activity Profile Participants will wear a chest-mounted heart rate monitor (Garmin HRM-PRO Run Dynamics strap) during the race. The device consists of an elastic strap with an embedded sensor that is worn directly against the skin, positioned horizontally around the chest, just below the pectoral muscles (breastbone), in accordance with manufacturer instructions. Prior to the race, a trained member of the research team will demonstrate proper placement and fit of the heart rate strap. Participants will be instructed to ensure the strap fits snugly but comfortably, allowing normal breathing and movement without excessive tightness. The strap does not deliver electrical stimulation or vibration; it passively records heart rate and movement data. Participants may adjust or remove the heart rate strap at any time during the race if they experience discomfort, skin irritation, or any other concern. Removal of the strap will not affect continued participation in the study or result in penalty. Heart rate (HR) and activity rates (via accelerometer measurements) will be measured continuously (1 hertz (Hz)) during the race with participants wearing a Garmin 945 GPS watch and a wearable device (i.e., the HRM-PRO Run Dynamics strap).
NSAID Questionnaire During the pre-race data collection period, participants will be asked if they have consumed any non-steroidal anti-inflammatory drugs prior to the start of the race (quantity and type (e.g., ibuprofen)). Once the race is completed, the same questionnaire will be used to ask participants if they consumed any NSAIDs during the race, and at what quantity.
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Being tested
- Sodium Bicarbonate (NaHCO3), Placebo
- Keywords
- ultra-endurance, bicarbonate, AKI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
The placebo product consists of the same sodium concentration as the intervention group receiving sodium bicarbonate.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start27 Jun 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI (Acute Kidney Injury) Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Western States Endurance Run Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519408
- Sponsor's protocol ID
- IHPL
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Severity of Acute Kidney Injury in Ultrarunners Competing in the Western States Endurance Run
- ClinicalTrials.gov ID
- NCT07519408
- Acronym / sponsor ID
- IHPL
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Keywords
- ultra-endurance, bicarbonate, AKI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Western States Endurance Run Research Foundation
- Study start
- 27 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a single-group, pre- and post-test design where participants will be assessed prior to the start of the WSER, upon completion of the race and 24 hours post-race. Approximately one hour prior to the race commencing, participants will be asked to void the entire contents of their bladder in a urine container in order to measure urine volume, flow rate and urine specific gravity (USG) to assess hydration status and for subsequent analysis of acute kidney injury (AKI) risk (insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinase 2 (TIMP-2), and neutrophil gelatinase-associated lipocalin (NGAL)). Participants will also be provided a Garmin 945 GPS watch and a wearable device (i.e., the HRM-PRO Run Dynamics strap) for the race. The system is a waterproof heartrate monitor strap with an embedded accelerometer that quantifies gait metrics (ground reaction force). At this time they will also have their weight measured, and complete a short questionnaire to document any recent intake of non-steroidal anti-inflammatory (NSAIDS) medication. Lastly, the research team will collect a small capillary sample (~ 300 microliters) of whole blood into a heparinised tube and immediately analyse the sample for creatinine (CR) and blood urea nitrogen (BUN) using a portable, point of care analyzer (i-STAT 1 Wireless, Abbott, Princeton).
Upon completing the WSER, participants will again be asked to provide a urine sample (following the pre-race methodology), have their weight measured, complete the questionnaire regarding additional NSAID use during the race, and lastly a final capillary blood sample for post-race analysis of CR and BUN. Participants will then be randomized into one of two groups (sodium bicarbonate (SB) or placebo), with one receiving a pre-packaged standard amount of either 15, 19, or 22 grams of sodium bicarbonate provided by Maurten (Maurten Bicarb System, MaurtenTM, Göteborg, SWE) depending on their body weight. MaurtenTM will also provide an equivalent placebo product. Participants will be asked to consume the SB or placebo, which is delivered in a patented hydrogel system (similar to a yogurt). The urine and blood sampling procedure will be repeated 24 hours post-race at a location to be determined.
All urine samples will be packed in an appropriately labeled biohazard container with cold packs, and brought back to the Arizona State University's Integrated Human Performance Lab (IHPL; Principle Investigator (PI)-Siegler) for measures of AKI risk with the research team. As per the Transportation Security Administration (TSA) regulations, biological specimens that are non-infectious and contain less than 30 mL of fluid in each container are permissible in checked baggage. The samples from each of the 3 races will be approximately 5 milliliters (mL) each subject (so estimated at 50 mL total for each of the 3 races).
Methodological Techniques \& Measurements:
Anthropometric Assessments (Descriptive Data) Participants will be asked to use the restroom to empty their bladder (this sample will be used for AKI biomarkers, urine volume and USG), after which measurements of height and body mass will be obtained. This measurement will occur pre- and post-race to estimate loss of body weight (e.g., dehydration).
Urine Volume and Specific Gravity (USG) Participants will be asked to void into graduated measuring containers (~ 900 mL), which will subsequently be used to calculate total urine volume pre-, post-race, and 24 hours post-race and normalize AKI markers. Once volume is obtained, samples from this measurement will be used to assess dehydration (USG) and for subsequent analysis of AKI (see Kidney Injury Markers). USG will be measured using a handheld refractometer (Atago PALTMSeries, Tokyo, JP).
Capillary Blood Draws Capillary blood (~ 300 microliters; 600 total) will be obtained from an index finger pre-, post-race and 24 hours post-race to measure creatinine (CR) and blood urea nitrogen (BUN) using a portable, point of care analyzer (i-STAT 1 Wireless, Abbott, Princeton).
Kidney Injury Markers AKI risk will be assessed using Enzyme-Linked Immunosorbent Assay (ELISA) kits to measure concentrations of insulin-like growth factor-binding protein 7 (IGFBP7) (RayBiotech Life, Peachtree Corners, GA), tissue inhibitor of metalloproteinase 2 (TIMP-2) (RayBiotech Life, Peachtree Corners, GA), and neutrophil gelatinase-associated lipocalin (NGAL) (Enzo Life Sciences, Farmingdale, NY). Urine samples will be centrifuged before analysis and resultant supernatant used for analyses. The kidney markers will be normalized to urine flow rate, considering changes in the urine production that may happen in dehydration conditions such as exercise in the heat. All ELISA analyses will be completed according to manufacturer guidelines.
Heart Rate and Activity Profile Participants will wear a chest-mounted heart rate monitor (Garmin HRM-PRO Run Dynamics strap) during the race. The device consists of an elastic strap with an embedded sensor that is worn directly against the skin, positioned horizontally around the chest, just below the pectoral muscles (breastbone), in accordance with manufacturer instructions. Prior to the race, a trained member of the research team will demonstrate proper placement and fit of the heart rate strap. Participants will be instructed to ensure the strap fits snugly but comfortably, allowing normal breathing and movement without excessive tightness. The strap does not deliver electrical stimulation or vibration; it passively records heart rate and movement data. Participants may adjust or remove the heart rate strap at any time during the race if they experience discomfort, skin irritation, or any other concern. Removal of the strap will not affect continued participation in the study or result in penalty. Heart rate (HR) and activity rates (via accelerometer measurements) will be measured continuously (1 hertz (Hz)) during the race with participants wearing a Garmin 945 GPS watch and a wearable device (i.e., the HRM-PRO Run Dynamics strap).
NSAID Questionnaire During the pre-race data collection period, participants will be asked if they have consumed any non-steroidal anti-inflammatory drugs prior to the start of the race (quantity and type (e.g., ibuprofen)). Once the race is completed, the same questionnaire will be used to ask participants if they consumed any NSAIDs during the race, and at what quantity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate | Experimental | Dietary Supplement: Sodium Bicarbonate (NaHCO3)volunteers will be provided 0.3g/kg body weight of sodium bicarbonate to be consumed after completing the Western States Endurance Run (100 miles) |
| placebo | Placebo comparator | Dietary Supplement: Placebovolunteers will be provide 0.3g/kg body weight of placebo (corn starch) to be consumed after the race. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Bicarbonate (NaHCO3)SB will be used to investigate whether adding a buffer exogenously to aid recovery helps in reducing the severity of acute kidney injury. | Dietary supplement | sodium bicarbonate |
| PlaceboThe placebo product consists of the same sodium concentration as the intervention group receiving sodium bicarbonate. | Dietary supplement | placebo |
Primary outcome
Insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinase 2 (TIMP-2), and neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: 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
urine biomarkers of acute kidney injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate (NaHCO3) in people with AKI (Acute Kidney Injury) Due to Trauma, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-like growth factor-binding protein 7 (IGFBP7), tissue inhibitor of metalloproteinase 2 (TIMP-2), and neutrophil gelatinase-associated lipocalin (NGAL) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.