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Fluid Replacement for Renal Considerations in Heat Stress

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women
Body mass index ≤35.0 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to twelve weeks
Awards & highlights

Study Summary

This trial will help determine if dehydration is a factor in the development of renal oxidative stress and inflammation, which could shed light on the epidemic of chronic kidney disease occurring in outdoor laborers.

Eligible Conditions
  • Kidney Dysfunction
  • Dehydration
  • Kidney Injury
  • Hyperthermia
  • Heat Exhaustion
  • Heat Stroke

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Both males and females.
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Your body mass index is less than or equal to 35.0 kg/m2.
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Both males and females are eligible.
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Your body mass index (BMI) is less than or equal to 35.0 kg/m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to twelve weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to twelve weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak urinary MCP-1
Peak urinary thioredoxin
Secondary outcome measures
Peak urinary [IGFBP7 x TIMP-2]
Renal artery blood velocity
Segmental artery blood velocity
Other outcome measures
Blood and plasma volume
Blood pressure
Thermography
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fluid replacementExperimental Treatment1 Intervention
Group II: No fluid replacementPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluid replacement
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
973 Previous Clinical Trials
982,832 Total Patients Enrolled
State University of New York at BuffaloOTHER
244 Previous Clinical Trials
49,439 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this experiment?

"The primary endpoint of this research project, measured over the course of up to twelve weeks, is peak urinary interleukin-18 levels. Secondary objectives include evaluating Peak urinary [IGFBP7 x TIMP-2] as a kidney injury marker and Urinary L-FABP in addition to monitoring Renal artery blood velocity for indications of altered kidney blood flow."

Answered by AI

What is the enrolment size of this research project?

"Affirmative. Clinicaltrials.gov demonstrates that this experimental trial, which was inaugurated on August 1st 2022, is recruiting patients at present. 20 volunteers are being sought for the study from one centre."

Answered by AI

What are the qualifications for enrolling in this research trial?

"This medical experiment is currently recruiting 20 individuals between 18 and 44 years old who are suffering from dehydration. To be eligible, applicants must meet gender requirements; have a body mass index that does not exceed 35 kg/m2; and self-report as being in good health."

Answered by AI

Is this research initiative currently recruiting participants?

"As recorded on clinicaltrials.gov, the recruitment process for this trial is underway - it was initiated on August 1st of 2022 and refined more recently in October 17th 2022."

Answered by AI

Is there an age cutoff for participation in this research endeavor?

"This study requires prospective participants to fall in the 18-44 age bracket. There are also 20 trials for minors and a separate 70 trials suited for elderly individuals aged over 65."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~7 spots leftby Mar 2025