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Electrolyte Solution

IV Saline for POTS

N/A
Waitlist Available
Led By Satish R Raj, MD MSCI
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female are eligible (although the majority of POTS patients are female)
Age between 18-65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-10 days between exercise tests
Awards & highlights

Study Summary

This trial will test whether saline can improve exercise capacity in people with POTS.

Who is the study for?
This trial is for adults aged 18-65 who have been diagnosed with Postural Tachycardia Syndrome (POTS) and can consent to participate. It's not suitable for pregnant individuals, those with conditions that cause rapid heartbeat due to other reasons like dehydration or medications, or if they are bedridden/chair-ridden.Check my eligibility
What is being tested?
The study is examining whether giving patients with POTS an IV infusion of saline can improve their ability to exercise. Participants will receive either the saline solution or a placebo during the trial.See study design
What are the potential side effects?
While receiving an IV infusion of saline is generally considered safe, potential side effects may include discomfort at the injection site, mild swelling, and in rare cases, electrolyte imbalance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am either male or female.
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-10 days between exercise tests
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-10 days between exercise tests for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in VO2max between saline day and placebo day
Secondary outcome measures
Cardiac output between exercise tests (inert gas rebreathing technique)
Exercise capacity/Maximal Load (Watts) during peak VO2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise Post SalineExperimental Treatment1 Intervention
Saline infusion 1L hours before exercise test
Group II: PlaceboPlacebo Group1 Intervention
Placebo given prior to exercise test
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~1050

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
669,087 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
869 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Satish R Raj, MD MSCIPrincipal InvestigatorVanderbilt University
19 Previous Clinical Trials
1,386 Total Patients Enrolled
7 Trials studying Postural Orthostatic Tachycardia Syndrome
567 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Saline (Electrolyte Solution) Clinical Trial Eligibility Overview. Trial Name: NCT01000350 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Exercise Post Saline, Placebo
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Saline Highlights & Side Effects. Trial Name: NCT01000350 — N/A
Saline (Electrolyte Solution) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01000350 — N/A

Frequently Asked Questions

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

Are individuals below the age of 55 eligible for this research project?

"As declared by the criteria for this trial, only individuals aged 18 or above and 65 or below are eligible to join."

Answered by AI

Am I eligible to take part in this experiment?

"This clinical trial is recruiting 40 individuals afflicted with the disorder, aged between 18 and 65. Men and women may both apply (though predominantly patients of this condition are female)."

Answered by AI

Are there any vacancies open to participants in this research?

"This research is no longer enrolling patients, as evidenced by clinicaltrials.gov which tracks the posting date of October 1st 2009 and last updated on August 22nd 2022. However, there are over a thousand other experiments actively recruiting participants at this time."

Answered by AI
~0 spots leftby Jun 2024