Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

October 3, 2025 updated by: Satish R. Raj, Vanderbilt University Medical Center

Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2195
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
  • Age between 18-65 years
  • Male and female are eligible (although the majority of POTS patients are female).
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
  • Pregnancy
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
  • Patients who are bedridden or chair-ridden

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Post Saline
Saline infusion 1L hours before exercise test
Drug: Saline
IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
Other Names:
  • 0.9% saline
  • Normal Saline
Placebo Comparator: Placebo
Placebo given prior to exercise test
Other: Placebo
Placebo x1 lactose tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in VO2max between saline day and placebo day
Time Frame: Within 2 week
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Within 2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity/Maximal Load (Watts) during peak VO2
Time Frame: Less than 2 weeks
Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Less than 2 weeks
Cardiac output between exercise tests (inert gas rebreathing technique)
Time Frame: 2-10 Days between exercise tests
2-10 Days between exercise tests

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Satish R Raj, MD MSCI, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimated)

October 23, 2009

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 3, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090942

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe