Saline Infusion for POTS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Must not be taking: Anti-hypertensives

Disqualifiers: Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with chronic orthostatic intolerance (difficulty standing due to blood pressure changes) or postural orthostatic tachycardia syndrome (POTS) manage salt in their bodies compared to healthy individuals. Researchers will use a saline (saltwater) infusion (Normal Saline) to determine if these groups differ in sodium conservation. Participants should either have a diagnosis of orthostatic intolerance or be a healthy control subject. This study may suit those who often feel dizzy or faint when standing up. As an unphased trial, it offers participants the opportunity to contribute to foundational research that could enhance understanding and treatment of these conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-hypertensive medications, you may not be eligible to participate.

What prior data suggests that this saline infusion is safe for patients with POTS?

Research has shown that normal saline, a simple saltwater solution, often helps people with postural orthostatic tachycardia syndrome (POTS). Studies have found that saline infusions can ease symptoms in POTS patients. However, some side effects may occur. An imbalance in blood acidity, known as hyperchloremic acidosis, might affect some individuals. Kidney function could also be impacted.

Despite these concerns, normal saline is usually well-tolerated in medical settings. It has helped many patients by reducing symptoms without causing major problems. Prospective trial participants should discuss any concerns with their doctor, especially if other health issues are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about saline infusion for POTS (Postural Orthostatic Tachycardia Syndrome) because it offers a straightforward and potentially effective way to manage symptoms by directly increasing blood volume. Unlike typical treatments for POTS, which often involve medications like beta-blockers or fludrocortisone to influence heart rate or blood pressure indirectly, saline infusion works by directly increasing the sodium and fluid levels in the body, which can help stabilize circulation. This method could provide immediate relief of symptoms, making it a promising option for those who need quick results.

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

Research has shown that administering saline through an IV can greatly benefit people with postural orthostatic tachycardia syndrome (POTS). Some studies have found that occasional saline infusions significantly reduce symptoms and improve the quality of life for these patients. Other research indicates that saline infusions can boost exercise ability in people with POTS. This trial will investigate the effects of saline infusion for sodium loading in managing POTS symptoms, aiming to enhance overall physical function and well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with orthostatic intolerance or POTS by the Vanderbilt Autonomic Dysfunction Center, as well as healthy controls. It's not suitable for those with an obvious or sudden cause of rapid heartbeat, high blood pressure (over 145/95 or on medication), abnormal EKG results, or if pregnant.

Inclusion Criteria

You have been diagnosed with orthostatic intolerance by a specific medical center, or you are a healthy control subject.

Exclusion Criteria

I have high blood pressure or am on medication for it.

I experience a rapid heartbeat when standing up.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive saline infusion for sodium loading to test salt handling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Normal Saline

Trial Overview The study aims to see if patients with chronic orthostatic intolerance or POTS have trouble conserving sodium in their urine compared to healthy people. Participants will receive normal saline (0.9%) during the trial.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

saline infusion for sodium loading

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

Approved in United States as Normal Saline for:

• Fluid replacement
• Electrolyte imbalance
• Hypovolemia

Approved in European Union as Normal Saline for:

• Fluid replacement
• Electrolyte imbalance
• Hypovolemia

Approved in Canada as Normal Saline for:

• Fluid replacement
• Electrolyte imbalance
• Hypovolemia

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

This multicenter trial aims to compare the effects of balanced crystalloids versus normal saline on plasma chloride concentration in patients with predicted severe acute pancreatitis, with a primary endpoint of measuring chloride levels on day 3 after enrollment.

The study will also assess secondary outcomes related to kidney health and overall clinical status, providing valuable data to inform future research on fluid therapy in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Normal Saline or Balanced Crystalloid on Plasma Chloride Concentration and Acute Kidney Injury in Patients With Predicted Severe Acute Pancreatitis: Protocol of a Phase II, Multicenter, Stepped-Wedge, Cluster-Randomized, Controlled Trial. Ye, B., Huang, M., Chen, T., et al.[2021]

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]

Over a 10-year study involving 2,306 patients across a large healthcare system, there were no reported local infusion reactions associated with the administration of 3% sodium chloride (NaCl), indicating its safety for use through peripheral IVs.

The findings suggest that 3% NaCl can be safely administered for treating conditions like hyponatremic encephalopathy without the risk of local infusion complications, which may encourage its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of 3% Sodium Chloride and Local Infusion Reactions. Moritz, ML., Ayus, JC., Nelson, JB.[2022]

Citations

1. 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.

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

Oral and intravenous hydration in the treatment of ... In a double blind placebo-controlled study, 70% of 20 patients with recurrent syncope given 120 mmol/d (2.76 g/d) of sodium chloride for 8 weeks showed ...

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

IV Saline for POTS · Info for Participants The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03365414

A Study to Systematically Assess the Efficacy and Safety of ... Outcome measures will be quantified and validated at the end of each study period and the percentage reduction of tachycardia will be determined at the ...

5. 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 ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3390096/

Diagnosis and management of postural orthostatic ... Sodium chloride 0.9% (Normal saline). Sodium chloride 0.9% infusion has been reported very beneficial in decreasing symptoms in POTS patients and improving ...

8. autonomicneuroscience.com autonomicneuroscience.com/article/S1566-0702(21)00136-3/fulltext

Vasovagal syncope and postural orthostatic tachycardia ... There are no data on the safety and efficacy of salt supplementation for orthostatic disorders in individuals with other comorbid conditions ...