Hot Weather; Adverse EffectNCT05458843
Renal Considerations in the Heat Stress Recommendations (Aim2)
A study testing Fluid replacement and No fluid replacement in people with Hot Weather; Adverse Effect and Kidney Dysfunction, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Hot Weather; Adverse Effect, Kidney Dysfunction, Kidney Injury
- What is being tested?
- Fluid replacement and No fluid replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 22 May 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- 18-44 y old
- Body mass index ≤35.0 kg/m2
- Self-reported to be healthy
Who cannot join
- 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)
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- 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+.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Public Health
Bloomington, Indiana, 47405-7109
About this study
Official title: Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)
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.
- Being tested
- Fluid replacement, No fluid replacement
- Medical subject headings
- Hyperthermia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid replacementProcedure or surgery
Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes.
No fluid replacementProcedure or surgery
Participants will not be permitted to drink.
| Study group | Role | What they receive |
|---|---|---|
| Fluid replacement | Experimental | Not described Receives: Procedure: Fluid replacement |
| No fluid replacement | Sham comparator | Not described Receives: Procedure: No fluid replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak urinary thioredoxin
Marker of renal oxidative stress
Measured: Through study completion, up to twelve weeks
Peak urinary MCP-1
Marker of renal inflammation
Measured: Through study completion, up to twelve weeks
Secondary outcomes (3)
Peak urinary [IGFBP7 x TIMP-2]
Kidney injury marker
Measured: Through study completion, up to twelve weeks
Renal artery blood velocity
Measure of kidney blood flow
Measured: Through study completion, up to twelve weeks
Segmental artery blood velocity
Measure of kidney blood flow
Measured: Through study completion, up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Aug 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot Weather; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York at Buffalo
- Responsible party
- Principal investigator, Zachary J. Schlader, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458843
- Sponsor's protocol ID
- 15402
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)
- ClinicalTrials.gov ID
- NCT05458843
- Acronym / sponsor ID
- 15402
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- State University of New York at Buffalo
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 14 Jul 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid replacement | Experimental | Procedure: Fluid replacement |
| No fluid replacement | Sham comparator | Procedure: No fluid replacement |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women
- 18-44 y old
- Body mass index ≤35.0 kg/m2
- Self-reported to be healthy
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Fluid replacementParticipants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes. | Procedure or surgery | Fluid replacement |
| No fluid replacementParticipants will not be permitted to drink. | Procedure or surgery | No fluid replacement |
Primary outcome
Peak urinary thioredoxin
Time frame: Through study completion, up to twelve weeks
Marker of renal oxidative stress
Peak urinary MCP-1
Time frame: Through study completion, up to twelve weeks
Marker of renal inflammation
3 secondary outcomes
Peak urinary [IGFBP7 x TIMP-2]
Time frame: Through study completion, up to twelve weeks
Renal artery blood velocity
Time frame: Through study completion, up to twelve weeks
Segmental artery blood velocity
Time frame: Through study completion, up to twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Related trials for Hot Weather; Adverse Effect
Recruiting
Beat the Heat Boston
Hot Weather; Adverse Effect, Heat Effect
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid replacement and No fluid replacement in people with Hot Weather; Adverse Effect and Kidney Dysfunction, run by Indiana University 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak urinary thioredoxin (time frame: Through study completion, up to twelve weeks). The study lists 2 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 8 Nov 2023.