HyperthermiaNCT05710978
Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain
A study testing Work Protocol in people with Hyperthermia and Kidney Injury, Acute, run by State University of New York at Buffalo at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Kidney Injury, Acute
- What is being tested?
- Work Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 8 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (18-39 years old)
- Regularly completes aerobic exercise at least 60 min per week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Education in Special Environments
Buffalo, New York, 14214
About this study
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
- Being tested
- Work Protocol
- Medical subject headings
- Hyperthermia, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work ProtocolOther
Participants will complete 4 hours of walking and cycling to a work:rest ratio of 3:1.
| Study group | Role | What they receive |
|---|---|---|
| Work Heat Stress | Experimental | Each participant will complete three consecutive days of heavy intensity aerobic work in a hot environment. Receives: Other: Work Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: 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.
Measured: 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.
Measured: Hour 5
Secondary outcomes (9)
NGAL concentration
Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.
Measured: Minute 0
NGAL concentration
Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.
Measured: Hour 4
NGAL concentration
Neutrophil gelatinase-associated lipocalin (NGAL) measures kidney injury.
Measured: Hour 5
Serum creatinine concentration
Serum creatinine concentration is a measure of kidney function.
Measured: Minute 0
Serum creatinine concentration
Serum creatinine concentration is a measure of kidney function.
Measured: Hour 4
Serum creatinine concentration
Serum creatinine concentration is a measure of kidney function.
Measured: Hour 5
Urine creatinine concentration
Urine creatinine concentration is a measure of kidney function.
Measured: Minute 0
Urine creatinine concentration
Urine creatinine concentration is a measure of kidney function.
Measured: Hour 4
Urine creatinine concentration
Urine creatinine concentration is a measure of kidney function.
Measured: Hour 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start13 Oct 2022
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Why it stopped: Grant proposal was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
- Investigators
- Riana R Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710978
- Sponsor's protocol ID
- STUDY00005847-Pilot
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once published, pooled and de-identified data will be made available to interested researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Assess Acute Kidney Injury Risk During Heat Strain
- ClinicalTrials.gov ID
- NCT05710978
- Acronym / sponsor ID
- STUDY00005847-Pilot
- Conditions
- Hyperthermia, Kidney Injury, Acute
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant proposal was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 2 Feb 2023 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Work Heat Stress | Experimental | Other: Work ProtocolEach participant will complete three consecutive days of heavy intensity aerobic work in a hot environment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals (18-39 years old)
- Regularly completes aerobic exercise at least 60 min per week
Key exclusion criteria (7 listed)
- 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.)
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 |
|---|---|---|
| Work ProtocolParticipants will complete 4 hours of walking and cycling to a work:rest ratio of 3:1. | Other | Work Heat Stress |
Primary outcome
[TIMP-2 x IGFBP-7] concentration
Time frame: Minute 0
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.
[TIMP-2 x IGFBP-7] concentration
Time frame: Hour 4
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.
[TIMP-2 x IGFBP-7] concentration
Time frame: Hour 5
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.
9 secondary outcomes
NGAL concentration
Time frame: Minute 0
NGAL concentration
Time frame: Hour 4
NGAL concentration
Time frame: Hour 5
Serum creatinine concentration
Time frame: Minute 0
Serum creatinine concentration
Time frame: Hour 4
Serum creatinine concentration
Time frame: Hour 5
Urine creatinine concentration
Time frame: Minute 0
Urine creatinine concentration
Time frame: Hour 4
Urine creatinine concentration
Time frame: Hour 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No. Once published, pooled and de-identified data will be made available to interested researchers upon request.
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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. This study is not recruiting at the moment.
Riana R Pryor, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Work Protocol in people with Hyperthermia and Kidney Injury, Acute, run by State University of New York at Buffalo at 1 site in United States.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
[TIMP-2 x IGFBP-7] concentration (time frame: Minute 0). The study lists 3 primary outcomes in all. 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 13 Nov 2023.