Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study

Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort.

Study Overview

• Status: Recruiting
• Conditions: Decision Tree Analysis
• Intervention / Treatment: Other: No intervention

Detailed Description

Scientific research focuses on limited parameters, aims to confirm hypotheses, and has minor uncertainties. In contrast, medical decisions involve many unknowns. Physicians must use all available knowledge to make the best decisions. However, decision-making can become unpredictable when limited evidence exists, leading to non-reproducible outcomes.

According to clinical guidelines, patients who need pre-kidney replacement therapy (pre-KRT) and opt for hemodialysis (HD) with a reasonable life expectancy should have arteriovenous (AV) access created. Nevertheless, constructing an AVF has limitations. [Additionally, the maturation rate of AVF is suboptimal. Therefore, after careful consideration of the patient's end-stage kidney disease (ESKD) life plan, the suggested order of AV access types and locations starts a native distal forearm radiocephalic AVF, followed by a native proximal forearm AVF, a forearm arteriovenous graft (AVG), then an upper arm AVG creation.[Lok et al., 2020] However, the decision-making process for selecting hemodialysis access is shared between patients, physicians, and the surgeon's discretion.

Therefore, clinical kidney practice requires effective decision-making to address ESKD life plan and AV access concerns while minimizing harm. Decision analysis models can bridge the gap between research and decision-making. Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Chih-Yang Chan, phd; Phone Number: +88672651147; Email: chanchihyang@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chih-Yang Chan, MD Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

chronic kidney disease (CKD) and were in the pre-kidney replacement therapy (pre-KRT) stage, requiring their first hemodialysis (HD) AV access creatio

Description

Inclusion Criteria:

- adult patients between the ages of 18 and 80 who were referred for primary hemodialysis (HD) AV access creation. We included those in the pre-kidney replacement therapy (pre-KRT) stage and those who in the early end-stage kidney disease (ESKD) urgently started HD without sufficient time to plan for AV access

Exclusion Criteria:

- patients who underwent a secondary AV access surgery, like a transposed radiobasilic AVF or a revision of AVG.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AVF-wrist	Other: No intervention; No intervention
AVF-elbow	Other: No intervention; No intervention
AVG-forearm	Other: No intervention; No intervention
AVG-elbow	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predicted AV access choices	identifying parameters that predicted AV access choices among the four types	postoperativ 3 -12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to determine factors affecting clinical use of the targeted AV access over a variable timeframe	The secondary objective was to determine factors affecting clinical use of the targeted AV access over a variable timeframe	postoperativ 3 -12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chih-Yang Chan, phd, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): May 7, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; AV graft; Arteriovenous Fistula; decision tree analysis
• Other Study ID Numbers: 202309052RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No