We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regional Citrate Anticoagulation in Plasma Exchange Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370200
First Posted: June 9, 2011
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manja Antonic, University Medical Centre Ljubljana
  Purpose

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.


Condition Intervention
Focal Segmental Glomerulosclerosis Guillain-Barre Syndrome Procedure: plasma exchange treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regional Citrate Anticoagulation in Plasma Exchange Treatment

Resource links provided by NLM:


Further study details as provided by Manja Antonic, University Medical Centre Ljubljana:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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 ]

Enrollment: 140
Study Start Date: April 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 4% citrate
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
the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid
Active Comparator: 15% citrate
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
the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • anemia Hb less than 90
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370200


Locations
Slovenia
Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Principal Investigator: Manja Antonič, MD Center for acute and complicated dialysis, UMCLjubljana
  More Information

Publications:
Responsible Party: Manja Antonic, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01370200     History of Changes
Other Study ID Numbers: 111/09/09
First Submitted: June 2, 2011
First Posted: June 9, 2011
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Manja Antonic, University Medical Centre Ljubljana:
citrate
anticoagulation
plasma exchange
efficacy

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Guillain-Barre Syndrome
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action