IV Saline for POTS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Acute dehydration, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a saline (salt water) infusion can help individuals with postural tachycardia syndrome (POTS) exercise more effectively. POTS causes the heart to race upon standing, making everyday activities challenging. The trial includes two groups: one receives the saline infusion before exercising, while the other receives a placebo (a treatment with no active ingredient). Individuals diagnosed with POTS who experience symptoms when standing may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding new methods for managing POTS symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with medical conditions explained by medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IV saline infusions can be a safe option for people with postural tachycardia syndrome (POTS). In one study with 39 patients who regularly received saline infusions, 79% experienced significant improvements. Saline is usually well-tolerated, but it can sometimes cause issues like an imbalance in blood acidity and may affect kidney function. Overall, the treatment is generally considered safe for most people, but potential side effects should be discussed with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Postural Orthostatic Tachycardia Syndrome (POTS) focus on managing symptoms through medications like beta-blockers, fludrocortisone, or lifestyle changes such as increased salt and fluid intake. However, this trial explores the use of intravenous (IV) saline, which is unique because it directly increases blood volume before exercise, potentially providing immediate relief from symptoms. Researchers are excited about this approach because it offers a rapid, non-pharmacological method to improve blood circulation and orthostatic tolerance, which could significantly enhance the quality of life for POTS patients during physical activities. Unlike traditional treatments, saline infusion may offer quicker symptom relief without the side effects associated with long-term medication use.

What evidence suggests that saline might be an effective treatment for POTS?

Research has shown that giving saline through an IV can help people with postural tachycardia syndrome (POTS) feel better. In this trial, some participants will receive a saline infusion of 1 liter before an exercise test. One study found that occasional saline infusions greatly reduced symptoms and improved the quality of life for those with POTS. Another study found that receiving 1 liter of IV saline had similar benefits to a medication called midodrine, known to help with POTS. These findings suggest that saline can effectively manage POTS symptoms and might also help people exercise more easily. ^{1 2 3 6 7}

Who Is on the Research Team?

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either male or female.

Able and willing to provide informed consent

You have been diagnosed with Postural Tachycardia Syndrome (POTS).

Exclusion Criteria

I have conditions like dehydration that cause rapid heartbeat when standing.

I am unable to get out of bed or a chair by myself.

Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an intravenous infusion of saline or placebo before exercise tests

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Saline

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise Post Saline Experimental Treatment 1 Intervention

Saline infusion 1L hours before exercise test

Group II: Placebo Placebo Group 1 Intervention

Placebo given prior to exercise test

Saline is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Normal Saline for:

• General wound care
• Eye irrigation
• Skin cleansing

Approved in European Union as Sodium Chloride Solution for:

• Wound cleaning
• Eye washing
• Skin disinfection

Approved in Canada as Physiological Saline for:

• Wound irrigation
• Eye flushing
• General medical use

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Balanced crystalloid solutions, like lactated Ringer's and Plasma-Lyte, are increasingly preferred over saline (0.9% sodium chloride) for intravenous fluid therapy in acutely ill patients due to their closer resemblance to extracellular fluid and fewer adverse effects on acid-base balance.

Research indicates that using balanced crystalloids can prevent hyperchloremic metabolic acidosis and may lower the risk of complications such as acute kidney injury and death compared to saline, suggesting a need to reconsider saline as the primary intravenous fluid in critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balanced Crystalloid Solutions. Semler, MW., Kellum, JA.[2022]

In a study of 706 administrations of 3% sodium chloride through peripheral venous catheters, 10.5% were associated with infusion-related adverse events (IRAE), primarily mild cases of infiltration or phlebitis.

The risk of IRAE increased with the duration of the infusion, suggesting that short-term peripheral administration of 3% sodium chloride may be safe in acute care settings, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of peripherally administered 3% hypertonic saline. Deveau, RF., Marino, KK., Crowley, KE., et al.[2023]

The study evaluated the safety and efficacy of a hypotonic 0.225% sodium chloride infusion in 20 critically ill patients with hypernatremia, showing a significant decrease in serum sodium levels from 156 to 143 mEq/L over 3-7 days (P < .001).

While the infusion effectively lowered sodium levels, it also indicated potential minor hemolysis, as evidenced by an increase in plasma free hemoglobin, suggesting that further research is needed to confirm the safety of this treatment before it can be routinely recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. Dickerson, RN., Maish, GO., Weinberg, JA., et al.[2015]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1566070222000108

Oral and intravenous hydration in the treatment of ... In a third nonblinded, noncontrolled, observational study of 21 patients with POTS, 1 L of IV saline was comparable to 10 mg of midodrine in reducing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28185102/

Effects of intermittent intravenous saline infusions in ... Intermittent IV infusions of saline dramatically reduce symptoms and improve quality of life in patients suffering from POTS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01000350

Intravenous (IV) Saline and Exercise in Postural ... The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1566070221001363

Salt supplementation in the management of orthostatic ... We found that short-term (~3 months) salt supplementation improves susceptibility to VVS and associated symptoms, with little effect on supine blood pressure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8103825/

Effect of High Dietary Sodium Intake in Patients with Postural ... Symptoms improve in children with POTS following supplementation with sodium chloride capsules (11), and acute sodium and volume expansion with intravenous ...

6. withpower.com withpower.com/trial/iv-saline-for-pots-26414

IV Saline for POTS · Info for Participants IV saline, specifically 0.9% sodium chloride, can cause issues like hyperchloremic acidosis (an imbalance in blood acidity) and may affect kidney function, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11472415/

Management of Postural Orthostatic Tachycardia Syndrome in ... Due to the limited data demonstrating efficacy and safety, pyridostigmine should not be used as an initial treatment for pediatric patients with ...