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

Occluded Totally Implanted Central Venous Catheter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270152
• Other study ID #: 0925-0586
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2011
• Last updated: January 4, 2011
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occluded Totally Implanted Central Venous Catheter

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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