Catheter-Related InfectionsNCT02970409
Heparin Versus Saline in Peripheral Venous Catheter
A study testing saline and Heparin in people with Catheter-Related Infections, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- saline and Heparin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteSpain
- Study dates
- 17 Oct 2015to 30 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with inserted PV Catheter within 24h from admission in internal medicine
Who cannot join
- hypersensibility to heparin
- active hemorrhage
- coagulation alterations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department
A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.
Read the detailed description
The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.
Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.
Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.
Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.
Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.
- Conditions
- Catheter-Related Infections
- Being tested
- saline, Heparin
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDevice
catheter lock using saline
HeparinDevice
catheter lock using Heparin
| Study group | Role | What they receive |
|---|---|---|
| heparin | Active comparator | Catheter Lock Therapy with Heparin Receives: Device: Heparin |
| saline | Experimental | Catheter Lock Therapy with saline Receives: Device: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .
Measured: Daily from catheter insertion until catheter withdraw(estimated 10 days)
Secondary outcomes (2)
catheter related infection rate
episodes of catheter related infection against number of days of exposure to catheter
Measured: Through study completion( estimated 2 year after Last patient in)
adverse events(number of catheter obstructions and coagulation alterations)
Measured: Through study completion (2 year afterLast patient in)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start17 Oct 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies 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
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970409
- Sponsor's protocol ID
- FIBHGM-ECNC002-2014
- Status last verified
- Dec 2018
- First submitted
- 15 Oct 2015
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department
- ClinicalTrials.gov ID
- NCT02970409
- Acronym / sponsor ID
- FIBHGM-ECNC002-2014
- Conditions
- Catheter-Related Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Study start
- 17 Oct 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 22 Nov 2016 (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.
A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.
Detailed description
The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.
Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.
Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.
Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.
Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heparin | Active comparator | Device: HeparinCatheter Lock Therapy with Heparin |
| saline | Experimental | Device: salineCatheter Lock Therapy with saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with inserted PV Catheter within 24h from admission in internal medicine
Key exclusion criteria (3 listed)
- hypersensibility to heparin
- active hemorrhage
- coagulation alterations
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 |
|---|---|---|
| salinecatheter lock using saline | Device | saline |
| Heparincatheter lock using Heparin | Device | heparin |
Primary outcome
complications
Time frame: Daily from catheter insertion until catheter withdraw(estimated 10 days)
prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .
2 secondary outcomes
catheter related infection rate
Time frame: Through study completion( estimated 2 year after Last patient in)
adverse events(number of catheter obstructions and coagulation alterations)
Time frame: Through study completion (2 year afterLast patient in)
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 20 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline and Heparin in people with Catheter-Related Infections, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 3 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 20 Dec 2018. 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 Spain. 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?
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?
complications (time frame: Daily from catheter insertion until catheter withdraw(estimated 10 days)). 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 20 Dec 2018.