Chronic Kidney DiseasesMuSTNCT05081648
Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention
A study testing CT MuST and Rope-ladder cannulation technique in people with Chronic Kidney Diseases and Hemodialysis, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Portugal.
Trial summary
The aims of this study are to: Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder). Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication
- What is being tested?
- CT MuST and Rope-ladder cannulation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesPortugal
- Study dates
- 3 Jan 2022to 30 Apr 2023
- 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
- Voluntarily agree to participate in the study and sign an informed consent;
- Are on a regular haemodialysis (HD) program with three weekly sessions;
- AVF has been in use for at least 4 weeks without incident;
- AVF with blood flow (Qa) ≥500 mL/min evaluated by thermodilution;
- AVF paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length;
- Adult patients
Who cannot join
- Those who decline to take part;
- Those who have undergone angiography or surgical intervention in the last 4 months in the AVF in use;
- Those who have undergone three or more interventions in the AVF in use;
- Those with use of anesthetic creams at cannulation sites.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
NephroCare Coimbra
Coimbra, 3025-04
Nephrocare Montijo
Montijo, 2870-281
NephroCare Vila Nova de Gaia
Vila Nova de Gaia, 4430-703
About this study
Official title: A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention
The aims of this study are to:
- Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Analyze the intensity of pain perceived by the patient with each cannulation technique under study.
Read the detailed description
The MuST is based on the association between the RL technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (BH) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).
- Conditions
- Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication, Hemodialysis Access Failure, Arteriovenous Fistula
- Being tested
- CT MuST, Rope-ladder cannulation technique
- Keywords
- Chronic Kidney Disease, Hemodialysis, Vascular access, Vascular Access Complication, Rope-ladder, Cannulation
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT MuSTProcedure or surgery
Multiple Single Cannulation Technique (MuST): Experimental technique
Rope-ladder cannulation techniqueProcedure or surgery
Standard cannulation technique( Rope-ladder)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Multiple Single Cannulation Technique (MuST) | Experimental | Not described Receives: Procedure: CT MuST |
| Control group: Rope-ladder cannulation technique (RL) | Other | Not described Receives: Procedure: Rope-ladder cannulation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular access survival rate
Vascular access (VA) survival rate at 12 months and determined by the percentage of fistulas in use from the beginning of the study to the date of the first clinical intervention by angioplasty or vascular surgery, to maintain or restore patency - "unassisted patency".
Measured: 12 months after start of study
Secondary outcomes (1)
Arteriovenous fistula survival rate
Arteriovenous fistula (AVF) survival rate at 12-month and determined by the percentage of fistulas in use from the study start to the date of access abandonment due to dysfunction, patient abandonment, or death, treatment change modality or study end.
Measured: 12 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start3 Jan 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multiple-center, prospective, non-blind, parallel-group, randomized controlled
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lisbon, Lisbon School of Nursing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081648
- Sponsor's protocol ID
- HD-MuST-01-PT
- Acronym
- MuST
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2021
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peralta R, Rocha R, Dias AS, Martins A, Matos JF, Ponce P, Bernardo A, Wammi A, Stauss-Grabo M, Stuard S, Trkulja M, Carvalho H, Dias O, Cristovao F. A Randomized Control Trial of MuST for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention. Kidney Med. 2026 Feb 16;8(5):101305. doi: 10.1016/j.xkme.2026.101305. eCollection 2026 May.
PubMed 42004653Peralta R, Wammi A, Stauss-Gabo M, Dias O, Carvalho H, Cristovao A. A randomised control trial protocol of MuST for vascular access cannulation in hemodialysis patients (MuST Study): contributions for a safe nursing intervention. BMC Nephrol. 2022 Jun 21;23(1):218. doi: 10.1186/s12882-022-02842-3.
PubMed 35729492
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention
- ClinicalTrials.gov ID
- NCT05081648
- Acronym / sponsor ID
- MuST / HD-MuST-01-PT
- Conditions
- Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication, Hemodialysis Access Failure, Arteriovenous Fistula
- Keywords
- Chronic Kidney Disease, Hemodialysis, Vascular access, Vascular Access Complication, Rope-ladder, Cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University of Lisbon, Lisbon School of Nursing
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Oct 2021 (actual)
- 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 aims of this study are to:
- Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Analyze the intensity of pain perceived by the patient with each cannulation technique under study.
Detailed description
The MuST is based on the association between the RL technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (BH) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multiple-center, prospective, non-blind, parallel-group, randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Multiple Single Cannulation Technique (MuST) | Experimental | Procedure: CT MuST |
| Control group: Rope-ladder cannulation technique (RL) | Other | Procedure: Rope-ladder cannulation technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily agree to participate in the study and sign an informed consent;
- Are on a regular haemodialysis (HD) program with three weekly sessions;
- AVF has been in use for at least 4 weeks without incident;
- AVF with blood flow (Qa) ≥500 mL/min evaluated by thermodilution;
- AVF paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length;
Key exclusion criteria (4 listed)
- Those who decline to take part;
- Those who have undergone angiography or surgical intervention in the last 4 months in the AVF in use;
- Those who have undergone three or more interventions in the AVF in use;
- Those with use of anesthetic creams at cannulation sites.
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 |
|---|---|---|
| CT MuSTMultiple Single Cannulation Technique (MuST): Experimental technique | Procedure or surgery | Intervention group: Multiple Single Cannulation Technique (MuST) |
| Rope-ladder cannulation techniqueStandard cannulation technique( Rope-ladder) | Procedure or surgery | Control group: Rope-ladder cannulation technique (RL) |
Primary outcome
Vascular access survival rate
Time frame: 12 months after start of study
Vascular access (VA) survival rate at 12 months and determined by the percentage of fistulas in use from the beginning of the study to the date of the first clinical intervention by angioplasty or vascular surgery, to maintain or restore patency - "unassisted patency".
1 secondary outcome
Arteriovenous fistula survival rate
Time frame: 12 months after start of study
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 13 Oct 2023.
- Derived from this study: PubMed 42004653Peralta R, Rocha R, Dias AS, Martins A, Matos JF, Ponce P, Bernardo A, Wammi A, Stauss-Grabo M, Stuard S, Trkulja M, Carvalho H, Dias O, Cristovao F. A Randomized Control Trial of MuST for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention. Kidney Med. 2026 Feb 16;8(5):101305. doi: 10.1016/j.xkme.2026.101305. eCollection 2026 May.
- Derived from this study: PubMed 35729492Peralta R, Wammi A, Stauss-Gabo M, Dias O, Carvalho H, Cristovao A. A randomised control trial protocol of MuST for vascular access cannulation in hemodialysis patients (MuST Study): contributions for a safe nursing intervention. BMC Nephrol. 2022 Jun 21;23(1):218. doi: 10.1186/s12882-022-02842-3.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT MuST and Rope-ladder cannulation technique in people with Chronic Kidney Diseases and Hemodialysis, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Portugal.
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 6 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Vascular access survival rate (time frame: 12 months after start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081648, which also lists 2 linked publications.
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 13 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.