What side effects are associated with this type of intervention?

Saline infusion, used to increase blood volume in CFS patients with hypovolemia, is generally well-tolerated but can cause side effects such as fluid overload, which may lead to swelling, hypertension, and in severe cases, heart failure. Other common treatments for CFS, like immunomodulatory therapies (e.g., valganciclovir), may cause gastrointestinal issues, headaches, and potential immunosuppression, increasing the risk of infections. Antiviral treatments can also lead to similar side effects, including nausea, diarrhea, and liver enzyme abnormalities.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Chronic Fatigue Syndrome (CFS) mentioned in the provided context. However, the context does discuss a study examining the use of saline infusion to address hypovolemia in CFS patients. This approach aims to increase blood volume, which may help alleviate some symptoms of CFS. Other treatments being studied for CFS include antiviral and immunomodulatory therapies, such as valganciclovir, which may offer benefits for certain subsets of patients.

What other types of research exist?

One promising alternative to saline infusion for addressing hypovolemia in Chronic Fatigue Syndrome patients is the use of hypertonic saline (1.07% saline), which has been shown to increase plasma volume more effectively than 0.9% saline. Another potential alternative could be the use of pharmacologic agents that target the underlying mechanisms of hypovolemia, such as vasopressin analogues, which have been studied in other conditions like septic shock. Further research and clinical trials are needed to confirm their efficacy and safety in CFS patients.

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Saline Infusion for Chronic Fatigue Syndrome

N/A

Recruiting

Led By Benjamin Natelson, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet the 2015 IOM case definition for ME/CFS

Ages 25 to 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves saline infusion which is generally safe and commonly used in medical settings, side effects are minimal but may include discomfort at the injection site or rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 25 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CPET testing

Hypovolemia

Total Blood Volume

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Saline InfusionExperimental Treatment1 Intervention

Group II: Sham InfusionPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saline Infusion

2008

N/A

~30

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Fatigue Syndrome (CFS) target various underlying mechanisms to alleviate symptoms. Saline infusion increases blood volume, addressing hypovolemia, which can improve circulation and reduce fatigue. Pyridostigmine, a cholinesterase inhibitor, enhances neuromuscular transmission, potentially alleviating fatigue linked to neuromuscular defects. Vitamin C infusion treatments, particularly those combined with glucocorticoid inducers, may modulate immune responses and improve adrenal function, addressing the multifaceted nature of CFS. These treatments are crucial as they target specific physiological abnormalities in CFS patients, offering symptomatic relief and improving quality of life.

The value of the dehydroepiandrosterone-annexed vitamin C infusion treatment in the clinical control of chronic fatigue syndrome (CFS). II. Characterization of CFS patients with special reference to their response to a new vitamin C infusion treatment.Fibromyalgia Syndrome: A Case Report on Controlled Remission of Symptoms by a Dietary Strategy.Characteristics and Clinical Manifestations of Pigmented Purpuric Dermatosis.