NIPH Clinical Trials Search

Specific clinical study on the safety of replacement fluids using hypertonic albumin solutions in plasma exchange therapy(Alb-PE-01)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Myasthenia gravis, Systemic lupus erythematosus, CIDP etc
Date of first enrollment	08/10/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Medication (new replacement fluid)

Outcome(s)

Primary Outcome

The Incidence rate of adverse events and side effects occurring during plasma exchange treatment

Secondary Outcome

(1)Safety Evaluation - Changes in vital signs measured before, during, and after plasma exchange - Changes in the following laboratory values measured before and after plasma exchange. Blood gas analysis also performed during plasma exchange Albumin level, Fibrinogen level, Electrolytes( Na, K, Ca, Mg, Cl, P) Blood gases(Bicarbonate ion ( HCO3-), ionized calcium concentration, pH (2)Efficacy Evaluation - Changes in the following laboratory values measured before and after plasma exchange Antibody levels( IgG,IgM,IgA)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	The study is open to those who meet all of the following criteria: - Patients (regardless of gender) who require inpatient treatment and simple plasma exchange therapy - Patients aged 18 years or older who have provided written consent from themselves or their legal representative
Exclude criteria	Those who meet the following criteria will be excluded: - Those deemed inappropriate as subjects of this study by the principal investigator.