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

Primary Purpose

Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
CT MuST
Rope-ladder cannulation technique
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease, Hemodialysis, Vascular access, Vascular Access Complication, Rope-ladder, Cannulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NephroCare Coimbra
  • Nephrocare Montijo
  • NephroCare Vila Nova de Gaia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group: Multiple Single Cannulation Technique (MuST)

Control group: Rope-ladder cannulation technique (RL)

Arm Description

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2021
Last Updated
October 12, 2023
Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
University of Lisbon, Lisbon School of Nursing
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1. Study Identification

Unique Protocol Identification Number
NCT05081648
Brief Title
Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention
Acronym
MuST
Official Title
A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
University of Lisbon, Lisbon School of Nursing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multiple-center, prospective, non-blind, parallel-group, randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group: Multiple Single Cannulation Technique (MuST)
Arm Type
Experimental
Arm Title
Control group: Rope-ladder cannulation technique (RL)
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
CT MuST
Intervention Description
Multiple Single Cannulation Technique (MuST): Experimental technique
Intervention Type
Procedure
Intervention Name(s)
Rope-ladder cannulation technique
Intervention Description
Standard cannulation technique( Rope-ladder)
Primary Outcome Measure Information:
Title
Vascular access survival rate
Description
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".
Time Frame
12 months after start of study
Secondary Outcome Measure Information:
Title
Arteriovenous fistula survival rate
Description
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.
Time Frame
12 months after start of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
NephroCare Coimbra
City
Coimbra
ZIP/Postal Code
3025-04
Country
Portugal
Facility Name
Nephrocare Montijo
City
Montijo
ZIP/Postal Code
2870-281
Country
Portugal
Facility Name
NephroCare Vila Nova de Gaia
City
Vila Nova De Gaia
ZIP/Postal Code
4430-703
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
35729492
Citation
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.
Results Reference
derived

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

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