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

Phase 2

Completed

• Conditions: Occluded Totally Implanted Central Venous Catheter
• Interventions: Drug: Ascorbic Acid

• Registration Number: NCT01270152
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Last Update Submitted: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 50 mg ascorbic acid	Ascorbic Acid	this arm received a dose of 50 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
group 100mg ascorbic acid	Ascorbic Acid	this arm received a dose of 100 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
group 200mg ascorbic acid	Ascorbic Acid	this arm received a dose of 200 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes

Primary Outcome Measures

Name	Time	Method
Restore patency	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

Name	Time	Method
Eosinophil count	within 24 hours	the count of eosinophils was determined by collecting blood sample immediately prior to administration of ascorbic acid and 24 hours after

Trial Locations

Locations (1)

Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil