Regional Citrate Anticoagulation in Plasma Exchange Treatment

Study Overview
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Brief Summary
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The investigators want to compare the efficacy of plasma exchange treatment with using two different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment. The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as anticoagulant during the plasma exchange procedure.

Detailed Description
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To compare the elimination rate of immunoglobulins in plasma exchange treatment by using two differently concentrated citrates for anticoagulation during plasma exchange procedure. At the same time we want to compare acid-base , electrolyte status and anticoagulation protocol in two citrate groups.

Official Title
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Regional Citrate Anticoagulation in Plasma Exchange Treatment

Conditions
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Focal Segmental Glomerulosclerosis, Guillain-Barre Syndrome

Intervention / Treatment
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* Procedure: plasma exchange treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who need plasma exchange treatment human albumins as a replacement fluid Exclusion Criteria: anemia Hb less than 90

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4% citrate<br>4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step | Procedure: plasma exchange treatment<br>* the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid<br>|
| Active Comparator: 15% citrate<br>15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step | Procedure: plasma exchange treatment<br>* the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants |  | the whole trial, approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants |  | the whole trial, approximately 3 years | 
| Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment. |  | the whole trial, approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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citrate, anticoagulation, plasma exchange, efficacy