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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Normal Saline for POTS?

Research suggests that while saline is commonly used as an intravenous fluid, it may cause issues like kidney injury and metabolic acidosis. However, in some cases, sodium chloride solutions have been effective in treating conditions like hyponatremia by increasing sodium levels in the blood. ^{1 2 3 4 5}

Is IV saline generally safe for humans?

IV saline, specifically 0.9% sodium chloride, can cause issues like hyperchloremic acidosis (an imbalance in blood acidity) and may affect kidney function, especially in surgical or critically ill patients. However, these effects are more pronounced with high chloride content solutions, and balanced solutions with lower chloride levels are often recommended for safety. ^{6 7 8 9 10}

How does saline treatment for POTS differ from other treatments?

Saline (normal saline, 0.9% sodium chloride) is unique for POTS (Postural Orthostatic Tachycardia Syndrome) as it is administered intravenously to quickly expand blood volume, which can help alleviate symptoms like dizziness and rapid heartbeat. Unlike other treatments that may focus on medication or lifestyle changes, saline directly increases blood volume, providing immediate relief. ^{1 5 11 12 13}

Research Team

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Balanced Crystalloid Solutions. [2022]

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

Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Hourly oral sodium chloride for the rapid and predictable treatment of hyponatremia. [2021]

4. Norway pubmed.ncbi.nlm.nih.gov

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

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

Safety of Continuous Peripheral Infusion of 3% Sodium Chloride Solution in Neurocritical Care Patients. [2018]

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

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

7. 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]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Sodium chloride 0.9%: nephrotoxic crystalloid?]. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[NaCl 0.9 % for volume substitution : blessing or curse?]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Association between continuous peripheral i.v. infusion of 3% sodium chloride injection and phlebitis in adults. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Volume management: peri-operatively and peri-interventionally]. [2021]

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

New Trends in the Utilization of Intravenous Fluids. [2021]