Regional Citrate Anticoagulation in Plasma Exchange Treatment

Not Applicable

Completed

• Conditions: Focal Segmental Glomerulosclerosis; Guillain-Barre Syndrome
• Interventions: Procedure: plasma exchange treatment

• Registration Number: NCT01370200
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• patients who need plasma exchange treatment
• human albumins as a replacement fluid

Exclusion Criteria

• anemia Hb less than 90

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4% citrate	plasma exchange treatment	4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
15% citrate	plasma exchange treatment	15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia