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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.

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.

Is saline infusion generally safe for humans?

Normal saline (0.9% sodium chloride) is generally considered safe for humans and is commonly used in medical settings. While the studies provided focus on 3% sodium chloride, which is more concentrated and can cause local reactions if not administered properly, normal saline does not have these risks and is widely used without significant safety concerns. ^{1 2 3 4 5}

How does the treatment of Normal Saline differ from other treatments for POTS?

Normal Saline is a simple saltwater solution used to increase blood volume and improve circulation, which can help manage symptoms of POTS (Postural Orthostatic Tachycardia Syndrome). Unlike other treatments that may involve medications affecting heart rate or blood pressure, Normal Saline works by directly increasing fluid volume in the body, making it a unique option for managing this condition. ^{6 7 8 9 10}

Research Team

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety of peripherally administered 3% hypertonic saline. [2023]

2. United States 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. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Administration of 3% Sodium Chloride and Local Infusion Reactions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Administration of 3% hypertonic saline via peripheral route: Is it really safe? [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Incidence of Adverse Events During Peripheral Administration of Sodium Chloride 3. [2018]

6. Norway pubmed.ncbi.nlm.nih.gov

[Treatment of hypovolemia with hypertonic saline solutions]. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Acid base and electrolyte changes after hypertonic saline (7.5%) infusion: a randomized controlled clinical trial. [2019]

8. Switzerland 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Hypertonic saline treatment of severe hyperkalemia in nonnephrectomized dogs. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Should chloride-rich crystalloids remain the mainstay of fluid resuscitation to prevent 'pre-renal' acute kidney injury?: con. [2022]