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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
Age between 18-65 years
Be older than 18 years old
Must not have
Patients who are bedridden or chair-ridden
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 week

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.
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.
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 between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to get out of bed or a chair by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in VO2max between saline day and placebo day
Secondary study objectives
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
~2130

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,792 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
890 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
~7 spots leftby Jun 2028
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