Saline Infusion for Chronic Fatigue Syndrome

Overseen By Benjamin Natelson, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Cardiac medications

Disqualifiers: Psychotic illness, Bipolar, Depression, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if giving a saltwater solution can help Chronic Fatigue Syndrome patients feel better after physical activity. It focuses on those who often feel worse after such activities.

Will I have to stop taking my current medications?

The trial excludes patients taking medications that would dampen cardiac response to exercise, so you may need to stop such medications. It's best to discuss your specific medications with the trial team.

Is saline infusion generally safe for humans?

Normal saline (0.9% sodium chloride) is generally safe for human use when administered properly. However, there have been adverse events when nonsterile simulation saline, not meant for human use, was mistakenly given to patients, leading to serious health issues. Properly administered sterile saline is widely used in medical settings without significant safety concerns. ^{1 2 3 4 5}

How does saline infusion differ from other treatments for chronic fatigue syndrome?

Saline infusion is unique because it involves administering a simple saltwater solution (0.9% sodium chloride) directly into the bloodstream, which is different from other treatments that might involve medications or supplements. This method is typically used to manage fluid balance and is not a standard treatment for chronic fatigue syndrome, making it a novel approach for this condition. ^{6 7 8 9 10}

Research Team

Benjamin Natelson, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for individuals aged 25 to 60 who have been diagnosed with Chronic Fatigue Syndrome (CFS) and experience Post-exertional malaise (PEM). It's not open to those with medical reasons for fatigue, on heart-affecting meds, or with recent histories of major psychiatric disorders, eating disorders, or substance abuse.

Inclusion Criteria

I have been diagnosed with ME/CFS according to the 2015 IOM criteria.

I am between 25 and 60 years old.

Exclusion Criteria

You have had issues with alcohol or drug abuse in the past 2 years.

I am on medication that affects my heart's response to exercise.

I have not had anorexia or bulimia in the last 5 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exercise Testing

Participants complete a maximal exercise test on 2 subsequent days with blood volume measured prior to each test

2 days

2 visits (in-person)

Randomization and Infusion

Patients with hypovolemia on day 1 are randomized to receive either a saline or sham infusion prior to the 2nd exercise test

1 day

Follow-up

Participants are monitored for safety and effectiveness after the exercise tests

2-4 weeks

Treatment Details

Interventions

• Saline Infusion (Procedure)

Trial Overview The study aims to understand cardiopulmonary function in CFS patients by having them do maximal exercise tests on two consecutive days. Some will receive a saline infusion before the second test if they show low blood volume initially. The goal is to see if this affects their PEM symptom.

Participant Groups

Group I: Saline Infusion Experimental Treatment 1 Intervention

Group II: Sham Infusion Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

Normal saline stored in polyolefin bags remained stable and showed no signs of precipitation, discoloration, or turbidity after being exposed to extreme temperatures (22, 50, and 70 °C) for up to one month.

Sodium and chloride concentrations in the saline solution were consistently within acceptable ranges, indicating that the solution is safe and compatible with its packaging under stress conditions, although real-world testing in ambulances is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we use normal saline stored under stress conditions? A simulated prehospital emergency medical setting. Rachid, O., Akkbik, M., Alkilany, AM., et al.[2023]

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 BaSICS trial will involve 11,000 critically ill patients across over 100 Brazilian intensive care units to compare the effects of balanced crystalloid solutions (Plasma-Lyte 148) versus saline on 90-day all-cause mortality.

The study will also investigate whether the rate of fluid infusion (rapid vs. slow) impacts patient outcomes, including renal failure and organ dysfunction, providing valuable insights into fluid management in critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. Zampieri, FG., Azevedo, LCP., Corrêa, TD., et al.[2022]

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]

Two patients at an urgent care facility were hospitalized after receiving nonsterile simulation saline IV fluids, which are not meant for human use, highlighting a serious safety issue in medical supply practices.

One patient developed severe complications, including sepsis and disseminated intravascular coagulation, although both patients survived, underscoring the potential risks of using inappropriate medical products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes from the field: Adverse events associated with administration of simulation intravenous fluids to patients--United States, 2014. Robyn, MP., Hunter, JC., Burns, A., et al.[2018]

In a study of 66 severe traumatic brain injury patients, balanced fluid (BF) therapy was found to maintain better electrolyte levels and reduce the risk of hyperchloremic metabolic acidosis compared to normal saline (NS) therapy over 24 hours.

Patients receiving BF therapy had significantly higher levels of calcium and magnesium, and lower instances of hyperchloremia and hypokalemia, indicating that BF may be a safer and more effective option for fluid management in neuro-ICU settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balanced Fluid Versus Saline-Based Fluid in Post-operative Severe Traumatic Brain Injury Patients: Acid-Base and Electrolytes Assessment. Hassan, MH., Hassan, WMNW., Zaini, RHM., et al.[2022]

In a study of 100 infants undergoing craniofacial surgery, those receiving the high-chloride Sterofundin ISO® solution experienced hyperchloremic metabolic acidosis more frequently (19 patients) compared to those receiving the lower-chloride Deltajonin® solution (2 patients).

The results suggest that using balanced isochloremic solutions like Deltajonin® may be safer for maintaining acid-base status in pediatric patients, as it resulted in better postoperative chloride levels and less acidosis compared to Sterofundin ISO®.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fluid Replacement with Sterofundin ISO&#174; vs. Deltajonin&#174; in Infants Undergoing Craniofacial Surgery-A Retrospective Study. Tan, B., Schütte, I., Engel, M., et al.[2023]

This study aims to compare the incidence of hyperchloremia in critically ill children receiving different intravenous fluids, specifically 0.9% sodium chloride versus balanced solutions like Plasma-Lyte 148 and Compound Sodium Lactate, with a target enrollment of 480 patients.

The primary outcome is to measure the increase in serum chloride levels within 48 hours, which will help determine if balanced solutions can reduce the risk of adverse outcomes associated with traditional saline therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU-a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial. Raman, S., Schibler, A., Marsney, RL., et al.[2021]

In a study of 144 emergency department patients with acute alcohol intoxication, treatment with intravenous normal saline did not significantly reduce the length of stay compared to observation alone, with both groups having similar EDLOS of approximately 287 minutes versus 274 minutes.

The addition of normal saline resulted in higher healthcare costs without improving intoxication symptoms or breath alcohol levels, suggesting that observation alone may be a more efficient approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous 0.9% sodium chloride therapy does not reduce length of stay of alcohol-intoxicated patients in the emergency department: a randomised controlled trial. Perez, SR., Keijzers, G., Steele, M., et al.[2021]

In a study involving 50 pediatric patients aged 6 to 18 years, 72% reported taste and odor disturbances after flushing IV lines with prefilled syringes of normal saline, compared to only 4% with freshly prepared saline, indicating a significant difference (p < 0.001).

The findings suggest that the plastic materials in commercially available prefilled syringes may leach volatile substances into the saline, causing these disturbances, highlighting the importance of preparation methods in minimizing patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taste and Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled or Freshly Prepared Syringes: Randomized Single-Blind Study. Mancini, D., Vaillancourt, R., Pouliot, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Can we use normal saline stored under stress conditions? A simulated prehospital emergency medical setting. [2023]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. [2022]

4. 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]

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

Notes from the field: Adverse events associated with administration of simulation intravenous fluids to patients--United States, 2014. [2018]

6. Malaysia pubmed.ncbi.nlm.nih.gov

Balanced Fluid Versus Saline-Based Fluid in Post-operative Severe Traumatic Brain Injury Patients: Acid-Base and Electrolytes Assessment. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Fluid Replacement with Sterofundin ISO&#174; vs. Deltajonin&#174; in Infants Undergoing Craniofacial Surgery-A Retrospective Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU-a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Intravenous 0.9% sodium chloride therapy does not reduce length of stay of alcohol-intoxicated patients in the emergency department: a randomised controlled trial. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Taste and Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled or Freshly Prepared Syringes: Randomized Single-Blind Study. [2019]