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

NCT01270152 | Completed Phase 2 DMC

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Occluded Totally Implanted Central Venous Catheter

Keywords

ascorbic acid; catheterization central venous; nursing care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Eosinophil count

  within 24 hours

Study Arms (3)

group 50 mg ascorbic acid

EXPERIMENTAL

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

group 100mg ascorbic acid

EXPERIMENTAL

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

group 200mg ascorbic acid

EXPERIMENTAL

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

Interventions

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

Also known as: Ascorbic Acid to restore catheter patency

group 100mg ascorbic acid; group 200mg ascorbic acid; group 50 mg ascorbic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
• No signs of inflammation in the area of the port.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Christiane I Vasques, Doc

  University of São Paulo, College of Nursing at Ribeirão Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 5, 2011

Record last verified: 2011-01

Locations

BR (1)