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

NCT05081648 | Completed

• 1 other identifier: HD-MuST-01-PT
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Arteriovenous fistula survival rate

  12 months after start of study

Study Arms (2)

Intervention group: Multiple Single Cannulation Technique (MuST)

EXPERIMENTAL

Procedure: CT MuST

Control group: Rope-ladder cannulation technique (RL)

OTHER

Procedure: Rope-ladder cannulation technique

Interventions

CT MuST PROCEDURE

Multiple Single Cannulation Technique (MuST): Experimental technique

Intervention group: Multiple Single Cannulation Technique (MuST)

Rope-ladder cannulation technique PROCEDURE

Standard cannulation technique( Rope-ladder)

Control group: Rope-ladder cannulation technique (RL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• University of Lisbon: collaborator
• Lisbon School of Nursing: collaborator

Study Sites (3)

NephroCare Coimbra

Coimbra, 3025-04, Portugal

Location

Nephrocare Montijo

Montijo, 2870-281, Portugal

Location

NephroCare Vila Nova de Gaia

Vila Nova de Gaia, 4430-703, Portugal

Location

Related Publications (1)

• Peralta 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.

  PMID: 35729492 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multiple-center, prospective, non-blind, parallel-group, randomized controlled

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: January 3, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-07

Locations

PT (3)