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Hydration Status for Kidney Injury (AMP2 Trial)

N/A
Waitlist Available
Led By Douglas J Casa, PhD
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intervention trial at the 220 minute mark
Awards & highlights

AMP2 Trial Summary

This study is evaluating whether a topical sodium bicarbonate lotion can help people stay hydrated during exercise.

Eligible Conditions
  • Kidney Injury
  • Electrolyte and Fluid Balance Disorders
  • Heat Stress
  • Dehydration
  • Edema
  • Sodium Retention

AMP2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase-specific pre session
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase-specific pre session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hydration Status - Change in 24-h Urine Osmolality
Hydration Status - Change in 24-h Urine USG
Hydration Status - Change in Acute Urine Osmolality
+33 more
Secondary outcome measures
Cardiovascular Function - Change in Blood Pressure
Cardiovascular Function - Change in Heart Rate Variability
Cognitive Differences - Changes in 2 Choice Reaction Time
+11 more

AMP2 Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Hydration StatusExperimental Treatment4 Interventions
Participants will be asked to partake in 5 total Intervention trials. Upon arrival to each trial, the participant will be asked to complete an 18-24 fluid restriction protocol to ensure their arrival within a dehydrated state. Depending on the phase randomization assigned to each participant, they will either be provided fluids to consume that will bring them back to an estimated level of 1% dehydration (total of 3/5 trials completed) or they will not be given any fluids to consume during the duration of the trial (total 2/5 trials completed). Participants will be considered completed with project participation upon the completion of each of the five trials outlined.
Group II: aminoVITAL - Amino Acid Rehydration SupplementActive Control1 Intervention
Participants will be provided with 3 servings of a commercially available amino acid rehydration supplement for consumption after the completion of the dehydrated heat stress intervention. Participants will be instructed to consume each serving in a time-dependent manner over the 24-hour period after dismissal from the laboratory after completion of the Intervention session.
Group III: PR Lotion Topical SolutionActive Control1 Intervention
Dose Dependent Response: Different doses relative to the participant's body weight will be provided for provision onto the skin before beginning data collection procedures. The 'larger' dose will be composed of 0.8g/kg of the PR Lotion while the 'smaller' dose will be composed of 0.4g/kg of the PR Lotion. Participants will be instructed to apply the lotion primarily to their lower extremities and upper extremities as needed. This lotion will be applied once during the Intervention session of each phase completed and will remain on the skin for approximately 3.5 hours.
Group IV: Placebo Lotion Topical SolutionPlacebo Group1 Intervention
A dose of lotion relative to the participant's body weight will be provided for provision onto the skin before beginning data collection procedures. This dose will be approximately 0.8g/kg of the Placebo Lotion. Similar to the PR Lotion, participants will be instructed to apply the lotion primarily to their lower extremities and upper extremities as needed. This lotion will be applied once during the Intervention session of each phase completed and will remain on the skin for approximately 3.5 hours.
Group V: Placebo Drink Supplement SolutionPlacebo Group1 Intervention
Participants will be provided with 3 servings of a placebo rehydration supplement for consumption after the completion of the dehydrated heat stress intervention. Participants will be instructed to consume each serving in a time-dependent manner over the 24-hour period after dismissal from the laboratory after completion of the Intervention session.

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor
183 Previous Clinical Trials
158,155 Total Patients Enrolled
AMP Human; Park City, UTUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,581 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Effect of AMP Human Sodium Bicarbonate Lotion on Dehydrated Heat Stress
Douglas J Casa 2021. "The Effect of AMP Human Sodium Bicarbonate Lotion on Dehydrated Heat Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092854.
~5 spots leftby Apr 2025
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