Regional Citrate Anticoagulation in Plasma Exchange Treatment

NCT ID: NCT01370200

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-12-31

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.

Conditions

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Focal Segmental Glomerulosclerosis Guillain-Barre Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4% citrate

4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step

Group Type ACTIVE_COMPARATOR

plasma exchange treatment

Intervention Type PROCEDURE

the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid

15% citrate

15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step

Group Type ACTIVE_COMPARATOR

plasma exchange treatment

Intervention Type PROCEDURE

the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid

Interventions

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plasma exchange treatment

the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Manja Antonic

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manja Antonič, MD

Role: PRINCIPAL_INVESTIGATOR

Center for acute and complicated dialysis, UMCLjubljana

Locations

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Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 19695068 (View on PubMed)

Other Identifiers

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111/09/09

Identifier Type: -

Identifier Source: org_study_id

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