Skip to main content
OpenTrials
Completed

NCT Number: NCT01270152

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Occluded Totally Implanted Central Venous Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ascorbic acid

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 5, 2011
Registry last updated
Jan 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.