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Trial record 42 of 990 for:    Heparin sodium

Comparative Effectiveness of 30%TSC and Heparin Lock Solution in Hemodialysis Catheters (CITRIM)

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ClinicalTrials.gov Identifier: NCT02563041
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Maristela Bohlke, Catholic University of Pelotas

Brief Summary:
BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed for patients without definitive vascular access. However, CVC use is associated with complications such as infection, thrombosis, and dysfunction, leading to higher mortality and expenditures. The aim of this study was to compare the effectiveness of 30% trisodium citrate (TSC30%) with heparin as CVC lock solution in preventing catheter-related bloodstream infections (CRBSI) and dysfunction in hemodialysis patients. METHODS: Randomized, double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked with heparin or TSC30% in adult hemodialysis patients.

Condition or disease Intervention/treatment Phase
Catheter Related Infection Drug: 30% TSC Drug: Heparin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of 30% Trisodium Citrate and Heparin Lock Solutions in Preventing Infection and Dysfunction of Hemodialysis Catheters: a Randomized Controlled Trial (CITRIM Trial)
Study Start Date : July 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 30%TSC
After each hemodialysis (HD) session, the catheter lumens were flushed with 0.9% sodium chloride and locked with a volume of 30%TSC solution exactly equivalent to the catheter internal lumen.
Drug: 30% TSC
The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.
Other Name: 30% trisodium citrate

Active Comparator: Heparin 5000 U/mL
After each hemodialysis (HD) session, the catheter lumens were flushed with 0.9% sodium chloride and locked with a volume of unfractionated sodium heparin 5000 U/mL solution exactly equivalent to the catheter internal lumen.
Drug: Heparin
The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.
Other Name: unfractionated sodium heparin 5000 U/mL




Primary Outcome Measures :
  1. Catheter related bloodstream infection [ Time Frame: through study completion, an average of 2 years ]


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

Inclusion Criteria:

  • patients older than 18 years and
  • with chronic or acute renal failure and
  • requiring hemodialysis through a catheter.

Exclusion Criteria:

  • patients admitted to the intensive care ward,
  • receiving a tunneled catheter,
  • patients with suspected heparin-induced thrombocytopenia,
  • patients with allergy to heparin or TSC30%,
  • patients with systemic or localized infection
  • pregnant women

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): NCT02563041


Sponsors and Collaborators
Catholic University of Pelotas
Investigators
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Principal Investigator: Maristela Bohlke, MD, PhD Catholic University of Pelotas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maristela Bohlke, MD PhD, Catholic University of Pelotas
ClinicalTrials.gov Identifier: NCT02563041     History of Changes
Other Study ID Numbers: UCPel
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Sodium Citrate
Heparin
Calcium heparin
Infection
Catheter-Related Infections
Pharmaceutical Solutions
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents