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Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270152
First Posted: January 5, 2011
Last Update Posted: October 12, 2017
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:
University of Sao Paulo
  Purpose
The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter

Condition Intervention Phase
Occluded Totally Implanted Central Venous Catheter Drug: Ascorbic Acid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Restore patency [ Time Frame: 60 minutes after administration of ascorbic acid ]
    the ascorbic acid is administered and remains inside the catheter within 60 minutes. The recovery of permeability is checked every 15 minutes until the maximum of 60 minutes


Secondary Outcome Measures:
  • Eosinophil count [ Time Frame: within 24 hours ]
    the count of eosinophils was determined by collecting blood sample immediately prior to administration of ascorbic acid and 24 hours after


Enrollment: 21
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 50 mg ascorbic acid
this arm received a dose of 50 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
Drug: Ascorbic Acid
comparing three different doses of ascorbic acid: 50 mg, 100 mg and 200 mg administered inside the catheter and maintained for up to 60 minutes
Other Name: Ascorbic Acid to restore catheter patency
Experimental: group 100mg ascorbic acid
this arm received a dose of 100 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
Drug: Ascorbic Acid
comparing three different doses of ascorbic acid: 50 mg, 100 mg and 200 mg administered inside the catheter and maintained for up to 60 minutes
Other Name: Ascorbic Acid to restore catheter patency
Experimental: group 200mg ascorbic acid
this arm received a dose of 200 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
Drug: Ascorbic Acid
comparing three different doses of ascorbic acid: 50 mg, 100 mg and 200 mg administered inside the catheter and maintained for up to 60 minutes
Other Name: Ascorbic Acid to restore catheter patency

Detailed Description:
Totally implanted catheter is often occluded and thrombolytic drugs are usually used to restore permeability. In Brazil, the ascorbic acid has been used successfully by a service specialist in cancer treatment. However, no literature on international research that evaluates the efficacy and safety of this procedure. That was why it was decided to develop this research.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
  • No signs of inflammation in the area of the port.

Exclusion Criteria:

  • Use of oral anticoagulants or intravenous administration in the last seven days;
  • Diagnostic and / or suspected infection in the totally implanted central venous catheter;
  • Rupture, displacement or fissure of the totally implanted central venous catheter;
  • Presence of thrombosis in the vein where the catheter is inserted.
  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): NCT01270152


Locations
Brazil
Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Christiane I Vasques, Doc University of São Paulo, College of Nursing at Ribeirão Preto
  More Information

Responsible Party: Christiane Inocencio Vasques, University of São Paulo, College of Nursing at Ribeirão Preto
ClinicalTrials.gov Identifier: NCT01270152     History of Changes
Other Study ID Numbers: 0925-0586
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: October 12, 2017
Last Verified: January 2011

Keywords provided by University of Sao Paulo:
ascorbic acid
catheterization central venous
nursing care

Additional relevant MeSH terms:
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances