Back to resultsRegional Citrate Anticoagulation in Plasma Exchange Treatment
Primary Purpose
Focal Segmental Glomerulosclerosis, Guillain-Barre Syndrome
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
plasma exchange treatment
Sponsored by
About this trial
This is an interventional treatment trial for Focal Segmental Glomerulosclerosis focused on measuring citrate, anticoagulation, plasma exchange, efficacy
Eligibility Criteria
Inclusion Criteria:
- patients who need plasma exchange treatment
- human albumins as a replacement fluid
Exclusion Criteria:
- anemia Hb less than 90
Sites / Locations
- Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
4% citrate
15% citrate
Arm Description
4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
Outcomes
Primary Outcome Measures
The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants
Secondary Outcome Measures
The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants
Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment.
Full Information
NCT ID
NCT01370200
First Posted
June 2, 2011
Last Updated
May 26, 2015
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT01370200
Brief Title
Regional Citrate Anticoagulation in Plasma Exchange Treatment
Official Title
Regional Citrate Anticoagulation in Plasma Exchange Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Segmental Glomerulosclerosis, Guillain-Barre Syndrome
Keywords
citrate, anticoagulation, plasma exchange, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4% citrate
Arm Type
Active Comparator
Arm Description
4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
Arm Title
15% citrate
Arm Type
Active Comparator
Arm Description
15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
Intervention Type
Procedure
Intervention Name(s)
plasma exchange treatment
Intervention Description
the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid
Primary Outcome Measure Information:
Title
The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants
Time Frame
the whole trial, approximately 3 years
Secondary Outcome Measure Information:
Title
The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants
Time Frame
the whole trial, approximately 3 years
Title
Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment.
Time Frame
the whole trial, approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who need plasma exchange treatment
human albumins as a replacement fluid
Exclusion Criteria:
anemia Hb less than 90
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manja Antonič, MD
Organizational Affiliation
Center for acute and complicated dialysis, UMCLjubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19695068
Citation
Antonic M, Gubensek J, Buturovic-Ponikvar J, Ponikvar R. Comparison of citrate anticoagulation during plasma exchange with different replacement solutions. Ther Apher Dial. 2009 Aug;13(4):322-6. doi: 10.1111/j.1744-9987.2009.00733.x.
Results Reference
background
Learn more about this trial
Regional Citrate Anticoagulation in Plasma Exchange Treatment
We'll reach out to this number within 24 hrs