Clinical trial NCT01598688: Cyclosporine (CSA) Level in Blood Samples Collected From Different Lines
Official title: Monitoring of Cyclosporine Serum Levels in Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Bone marrow transplantation
Hematopoietic stem cell transplantation
Medication management
Nursing care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-05-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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;
* Received cyclosporine administration through this device.

Exclusion Criteria:

* Patients who received cyclosporine infusion through a catheter line other than the one established for this goal.

Primary outcomes:
measure: Cyclosporine levels in blood samples
timeFrame: 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.
Secondary outcomes:
measure: Renal function
timeFrame: 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.
measure: Liver function
timeFrame: 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.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo at Ribeirão Preto College of Nursing
name: Livia M Garbin, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo at Ribeirão Preto College of Nursing
name: Emilia C Carvalho, RN, PhD
role: STUDY_DIRECTOR
References: