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

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

The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter

Study Overview

• Status: Completed
• Conditions: Occluded Totally Implanted Central Venous Catheter
• Intervention / Treatment: Drug: Ascorbic Acid

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Ascorbic Acid to restore catheter patency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restore patency	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	60 minutes after administration of ascorbic acid

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eosinophil count	the count of eosinophils was determined by collecting blood sample immediately prior to administration of ascorbic acid and 24 hours after	within 24 hours

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Christiane I Vasques, Doc, University of São Paulo, College of Nursing at Ribeirão Preto

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2011
• Last Update Submitted That Met QC Criteria: January 4, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: ascorbic acid; nursing care; catheterization central venous
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 0925-0586