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

U

University of Sao Paulo

Status and phase

Completed
Phase 2

Conditions

Occluded Totally Implanted Central Venous Catheter

Treatments

Drug: Ascorbic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01270152
0925-0586

Details and patient eligibility

About

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

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

21 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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