Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

Chronic Kidney Diseases Clinical Trial

— MuST  

Official title:

A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081648
• Other study ID #: HD-MuST-01-PT
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2023
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

• Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Diseases
• Fistula
• Hemodialysis
• Hemodialysis Access Failure
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Access Complication

Intervention

Procedure:
• CT MuST
Multiple Single Cannulation Technique (MuST): Experimental technique
• Rope-ladder cannulation technique
Standard cannulation technique( Rope-ladder)

Locations

Country	Name	City	State
Portugal	NephroCare Coimbra	Coimbra
Portugal	Nephrocare Montijo	Montijo
Portugal	NephroCare Vila Nova de Gaia	Vila Nova De Gaia

Sponsors (3)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Lisbon School of Nursing, University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	12 months after start of study
Secondary	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.	12 months after start of study