Cyclosporine (CSA) Level in Blood Samples Collected From Different Lines

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Livia Maria Garbin, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01598688
First received: May 7, 2012
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to verify whether differences exist in cyclosporine levels between the samples collected through peripheral venous access, the catheter line used to infuse the drug and the line not used for infusion immediately after interrupting the drug infusion or five minutes after the interruption.


Condition Intervention
Hematopoietic Stem Cell Transplantation
Other: Blood collection immediately after interrupting CSA infusion
Other: Blood collection five minutes after interrupting CSA infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Monitoring of Cyclosporine Serum Levels in Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Cyclosporine levels in blood samples [ Time Frame: At 1 day after the start of the infusion of the drug, and after every seven days during the period the patient is receiving intravenous infusion, an expected average of 4 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: Daily since the start of the infusion of the drug, during the period the patient is receiving intravenous infusion, an expected average of 4 weeks. ] [ Designated as safety issue: Yes ]
  • Liver function [ Time Frame: Daily since the start of the infusion of the drug, during the period the patient is receiving intravenous infusion, an expected average of 4 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blood collection immediately after interrupting the drug
Blood samples will be collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion immediately after interrupting the drug infusion.
Other: Blood collection immediately after interrupting CSA infusion

Blood samples will be collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion immediately after interrupting the drug infusion.

For peripheral blood collection, venous access will be established with a small gauge needle.

The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL.

Other Name: Immediate collection
Experimental: Blood collection five minutes after interrupting the drug
Blood samples will be collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion five minutes after interrupting the drug infusion.
Other: Blood collection five minutes after interrupting CSA infusion

Blood samples will be collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion five minutes after interrupting the drug infusion.

For peripheral blood collection, venous access will be established with a small gauge needle.

The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL.

Other Name: Five minutes

Detailed Description:

Cyclosporine is an immunosuppressant that prevents graft-versus-host disease, has a narrow therapeutic window, and causes nephrotoxicity. For cyclosporine infusion, a tunneled central venous access device is used; however due to the lipophilic properties of the drug, it can adsorb to the catheter surface and falsely raise cyclosporine concentrations in blood specimens. Some authors recommend sample collection through peripheral access only. Others, however, have shown that these can be collected through the catheter line not used to infuse the drug. Controversies still exist, though, regarding the best timing and blood volume to be discarded to collect the sample.

The hypothesis adopted was that drug adsorption occurs in the line used for infusion. Therefore, there is no statistical or clinical difference between the blood sample collected from the peripheral venous access and from the line not used for cyclosporine infusion. Additionally, this difference becomes smaller when waits five minutes between the interruption of the infusion of the drug and the collection of the blood sample.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age who are receiving an allogeneic hematopoietic stem cell transplantation;
  • Have a tunneled central venous access device with at least two lines implanted;
  • Receive cyclosporine administration through this device.

Exclusion Criteria:

  • Patients who receive cyclosporine infusion through a catheter line other than the one established for this goal.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598688

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil, 14048-900
Contact: Livia M Garbin, RN    55 1636024408 ext 4408    liviagarbin@usp.br   
Principal Investigator: Livia M Garbin, RN         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Livia M Garbin, RN University of Sao Paulo at Ribeirão Preto College of Nursing
Study Director: Emilia C Carvalho, RN, PhD University of Sao Paulo at Ribeirão Preto College of Nursing
  More Information

No publications provided

Responsible Party: Livia Maria Garbin, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01598688     History of Changes
Other Study ID Numbers: CSADOC
Study First Received: May 7, 2012
Last Updated: May 10, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Bone marrow transplantation
Hematopoietic stem cell transplantation
Medication management
Nursing care

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014