Chronic Hemodialysis PatientsNeedlesNCT00840372
Semi-blunt Needles: is Outcome Better?
An observational study of Chronic Hemodialysis Patients and Vascular Abord: Native Arterio-venous Fistula, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hemodialysis Patients, Vascular Abord: Native Arterio-venous Fistula, Buttonhole Cannulation
- What is being tested?
- Buttonhole cannulation with semi-blunt needles
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to Mar 2009
- Phase
- Observational
- 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
Study population: Chronic hemodialysis patients dialyzed in Cliniques Universitaires Saint-Luc by a native arterio-venous fistula
Who may be able to join
- Chronic hemodialysis patients
- Aged 18 years or more
- Dialyzed by a native arterio-venous fistula
- Cannuled by buttonhole method with blunt needles
Who cannot join
- Acute hemodialysis
- Puncture with 14G needles
- Puncture with a sole needle
- Arterio-venous grafts
- Patients transferred from another centre
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent.
Inclusion criteria and study design are detailed below.
- Conditions
- Chronic Hemodialysis Patients, Vascular Abord: Native Arterio-venous Fistula, Buttonhole Cannulation
- Being tested
- Buttonhole cannulation with semi-blunt needles
- Keywords
- Blunt needles, Semi-blunt needles, Buttonhole cannulation method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buttonhole cannulation with semi-blunt needlesProcedure or surgery
Use of semi-blunt needles, compared to blunt needles, at every dialysis session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chronic hemodialysis patients, native arterio-venous fistula Receives: Procedure: Buttonhole cannulation with semi-blunt needles | |
| 2 | Chronic hemodialysis patients, native arterio-venous fistula Receives: Procedure: Buttonhole cannulation with semi-blunt needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AVF hematomes
Measured: Two months
Incidence of use of sharp needles
Measured: Two months
Secondary outcomes (2)
Incidence of trampoline-effect
Measured: Two months
Incidence of AVF infections
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hemodialysis PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Investigators
- Laura Labriola, M.D., Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840372
- Sponsor's protocol ID
- Needles
- Other IDs
- Semi-blunt needles
- Acronym
- Needles
- Status last verified
- Sep 2009
- First submitted
- 9 Feb 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-blunt Needles: is Outcome Better?
- ClinicalTrials.gov ID
- NCT00840372
- Acronym / sponsor ID
- Needles / Needles
- Conditions
- Chronic Hemodialysis Patients, Vascular Abord: Native Arterio-venous Fistula, Buttonhole Cannulation
- Keywords
- Blunt needles, Semi-blunt needles, Buttonhole cannulation method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Feb 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 aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent.
Inclusion criteria and study design are detailed below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Buttonhole cannulation with semi-blunt needlesChronic hemodialysis patients, native arterio-venous fistula |
| 2 | – | Procedure: Buttonhole cannulation with semi-blunt needlesChronic hemodialysis patients, native arterio-venous fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hemodialysis patients dialyzed in Cliniques Universitaires Saint-Luc by a native arterio-venous fistula
Key inclusion criteria (4 listed)
- Chronic hemodialysis patients
- Aged 18 years or more
- Dialyzed by a native arterio-venous fistula
- Cannuled by buttonhole method with blunt needles
Key exclusion criteria (5 listed)
- Acute hemodialysis
- Puncture with 14G needles
- Puncture with a sole needle
- Arterio-venous grafts
- Patients transferred from another centre
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 |
|---|---|---|
| Buttonhole cannulation with semi-blunt needlesUse of semi-blunt needles, compared to blunt needles, at every dialysis session | Procedure or surgery | 1, 2 |
Primary outcome
Incidence of AVF hematomes
Time frame: Two months
Incidence of use of sharp needles
Time frame: Two months
2 secondary outcomes
Incidence of trampoline-effect
Time frame: Two months
Incidence of AVF infections
Time frame: Two months
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 29 Sep 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.
Laura Labriola, M.D. principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hemodialysis Patients and Vascular Abord: Native Arterio-venous Fistula, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 5 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 29 Sep 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 Belgium. 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?
Incidence of AVF hematomes (time frame: Two months). The study lists 2 primary outcomes in all. 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 29 Sep 2009.