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Clinical Trials/NCT05081648
NCT05081648
Completed
Not Applicable

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

Fresenius Medical Care Deutschland GmbH3 sites in 1 country101 target enrollmentJanuary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
Fresenius Medical Care Deutschland GmbH
Enrollment
101
Locations
3
Primary Endpoint
Vascular access survival rate
Status
Completed
Last Updated
2 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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".

Secondary Outcomes

  • Arteriovenous fistula survival rate(12 months after start of study)

Study Sites (3)

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