BacteremiaCVCLSNCT00862966
Central Venous Catheter Lock Solution
A study testing citrate and heparin in people with Bacteremia, run by University Medical Center, Tuzla at 1 site in Bosnia and Herzegovina.
Trial summary
The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia
- What is being tested?
- citrate and heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of end stage renal disease
Who cannot join
- Patients refusing randomization
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Department of Dialysis
Tuzla, TK, 75000
Goran Imamovic, MD,PhD, +387 61 194 131, goran_imamovic@bih.net.ba
Goran Imamovic, MD, PhD
About this study
Official title: Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution
The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.
- Conditions
- Bacteremia
- Being tested
- citrate, heparin
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrateOther
comparison of different catheter lock solutions
heparinOther
comparison of different lock solutions
| Study group | Role | What they receive |
|---|---|---|
| citrate | Experimental | Not described Receives: Other: citrate |
| heparin | Active comparator | Not described Receives: Other: heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower incidence of infection
Measured: 1 year
Secondary outcomes (1)
lower incidence of thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Tuzla
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862966
- Sponsor's protocol ID
- UMC-02-139
- Acronym
- CVCLS
- Status last verified
- Mar 2009
- First submitted
- 13 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution
- ClinicalTrials.gov ID
- NCT00862966
- Acronym / sponsor ID
- CVCLS / UMC-02-139
- Conditions
- Bacteremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Center, TuzlaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 17 Mar 2009 (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 purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citrate | Experimental | Other: citrate |
| heparin | Active comparator | Other: heparin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of end stage renal disease
Key exclusion criteria (1 listed)
- Patients refusing randomization
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 |
|---|---|---|
| citratecomparison of different catheter lock solutions | Other | citrate |
| heparincomparison of different lock solutions | Other | heparin |
Primary outcome
lower incidence of infection
Time frame: 1 year
1 secondary outcome
lower incidence of thrombosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citrate and heparin in people with Bacteremia, run by University Medical Center, Tuzla at 1 site in Bosnia and Herzegovina.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Mar 2009. 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 Bosnia and Herzegovina. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goran Imamovic, MD, PhD (+387 61 194 131, goran_imamovic@bih.net.ba), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower incidence of infection (time frame: 1 year). 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 17 Mar 2009.