Saline Infusion for Chronic Fatigue Syndrome
Recruiting in Palo Alto (17 mi)
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.
12345How 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.
678910Eligibility 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.
+2 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Saline InfusionExperimental Treatment1 Intervention
Group II: Sham InfusionPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Can we use normal saline stored under stress conditions? A simulated prehospital emergency medical setting. [2023]Data on stability and suitability to use normal saline stored under stress conditions in ambulances is lacking.
Safety of peripherally administered 3% hypertonic saline. [2023]Administration of 3% sodium chloride through a peripheral venous catheter is associated with risk of infusion-related adverse events (IRAE) due to its high osmolarity. Given this concern and the paucity of data regarding these events, many hospitals have policies that require central line administration of 3% sodium chloride.
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. [2022]The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown.
Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. [2015]The purpose of this study was to evaluate the safety and efficacy of central venous administration of a hypotonic 0.225% sodium chloride (one-quarter normal saline [¼ NS]) infusion for critically ill patients with hypernatremia.
Notes from the field: Adverse events associated with administration of simulation intravenous fluids to patients--United States, 2014. [2018]On December 23, 2014, the New York State Department of Health (NYSDOH) was notified of adverse health events in two patients who had been inadvertently administered nonsterile, simulation 0.9% sodium chloride intravenous (IV) fluids at an urgent care facility. Simulation saline is a nonsterile product not meant for human or animal use; it is intended for use by medical trainees practicing IV administration of saline on mannequins or other training devices. Both patients experienced a febrile illness during product administration and were hospitalized; one patient developed sepsis and disseminated intravascular coagulation. Neither patient died. Staff members at the clinic reported having ordered the product through their normal medical supply distributor and not recognizing during administration that it was not intended for human use.
Balanced Fluid Versus Saline-Based Fluid in Post-operative Severe Traumatic Brain Injury Patients: Acid-Base and Electrolytes Assessment. [2022]Normal saline (NS) is a common fluid of choice in neurosurgery and neuro-intensive care unit (ICU), but it does not contain other electrolytes and has the potential to cause hyperchloremic metabolic acidosis with prolonged infusion. These problems may be reduced with the availability of balanced fluid (BF), which becomes a more physiological isotonic solution with the presence of complete electrolyte content. This study aimed to compare the changes in electrolytes and acid-base between NS and BF (Sterofundin® ISO) therapy for post-operative severe traumatic brain injury (TBI) patients in neuro-ICU.
Comparison of Fluid Replacement with Sterofundin ISO® vs. Deltajonin® in Infants Undergoing Craniofacial Surgery-A Retrospective Study. [2023]In recent decades, infusion solutions such as NaCl 0.9% and lactate Ringer's solution have been replaced in clinical practice. Since 2017, the national guidelines for perioperative infusion therapy in children recommend balanced isotonic solutions to maintain fluid balance. The composition of balanced infusion solutions varies with respect to their electrolyte content. Hyperchloremia may be mistaken for hypovolemia and may interfere with volume therapy in pediatric patients. Sterofundin ISO® balanced solution contains 127 mmol/L chloride and may cause hyperchloremic acidosis if administered in large volumes.
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]Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plasma-Lyte 148 and Compound Sodium Lactate, represent potential alternatives but the evidence on optimal fluid choices in critically ill children remains scarce. This study aims to demonstrate whether balanced solutions, when used as intravenous fluid therapy, are able to reduce the incidence of a rise in serum chloride level compared to 0.9% sodium chloride in critically ill children.
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]I.v. 0.9% sodium chloride (normal saline) is frequently used to treat ED patients with acute alcohol intoxication despite the lack of evidence for its efficacy.
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]Previous studies have reported the occurrence of taste and odour disturbances among patients undergoing IV flush with prefilled syringes of 0.9% sodium chloride (normal saline [NS]). These disturbances have been attributed to the leaching of volatile substances into the NS from the plastic of the syringe. To date, there have been no studies comparing the occurrence of taste and odour disturbances with different NS preparations.