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

Study Overview
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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

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.

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

Conditions
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Occluded Totally Implanted Central Venous Catheter

Intervention / Treatment
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* Drug: Ascorbic Acid


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 50 mg ascorbic acid<br>this arm received a dose of 50 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes | Drug: Ascorbic Acid<br>* 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<br>* Other names: Ascorbic Acid to restore catheter patency;|
| Experimental: group 100mg ascorbic acid<br>this arm received a dose of 100 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes | Drug: Ascorbic Acid<br>* 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<br>* Other names: Ascorbic Acid to restore catheter patency;|
| Experimental: group 200mg ascorbic acid<br>this arm received a dose of 200 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes | Drug: Ascorbic Acid<br>* 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<br>* Other names: Ascorbic Acid to restore catheter patency;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascorbic acid, catheterization central venous, nursing care