Occluded Totally Implanted Central Venous CatheterPhase 2NCT01270152
Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter
A Phase 2 study testing Ascorbic Acid in people with Occluded Totally Implanted Central Venous Catheter, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occluded Totally Implanted Central Venous Catheter
- What is being tested?
- Ascorbic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
- No signs of inflammation in the area of the port.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: 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
Read the detailed 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.
- Being tested
- Ascorbic Acid
- Keywords
- ascorbic acid, catheterization central venous, nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Ascorbic Acid to restore catheter patency
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes after administration of ascorbic acid
Secondary outcomes (1)
Eosinophil count
the count of eosinophils was determined by collecting blood sample immediately prior to administration of ascorbic acid and 24 hours after
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occluded Totally Implanted Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Christiane I Vasques, Doc, Principal investigator, University of São Paulo, College of Nursing at Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270152
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2011
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter.
- ClinicalTrials.gov ID
- NCT01270152
- Acronym / sponsor ID
- 0925-0586
- Keywords
- ascorbic acid, catheterization central venous, nursing care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 50 mg ascorbic acid | Experimental | Drug: Ascorbic Acidthis arm received a dose of 50 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes |
| group 100mg ascorbic acid | Experimental | Drug: Ascorbic Acidthis arm received a dose of 100 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes |
| group 200mg ascorbic acid | Experimental | Drug: Ascorbic Acidthis arm received a dose of 200 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
- No signs of inflammation in the area of the port.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Ascorbic Acid to restore catheter patencycomparing three different doses of ascorbic acid: 50 mg, 100 mg and 200 mg administered inside the catheter and maintained for up to 60 minutes | Drug | group 100mg ascorbic acid, group 200mg ascorbic acid, group 50 mg ascorbic acid |
Primary outcome
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
1 secondary outcome
Eosinophil count
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane I Vasques, Doc principal investigator
University of São Paulo, College of Nursing at Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid in people with Occluded Totally Implanted Central Venous Catheter, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restore patency (time frame: 60 minutes after administration of ascorbic acid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2011.