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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Occluded Totally Implanted Central Venous Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type 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

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type 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

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Ascorbic Acid to restore catheter patency

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No