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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:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01270152
First received: January 4, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Restore patency [ Time Frame: 60 minutes after administration of ascorbic acid ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013