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Recruiting NCT06364449

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

Observational Decision Tree Analysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Decision Tree Analysis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • predicted AV access choices [Time frame: postoperativ 3 -12 months]
Secondary outcome measures (1)
  • to determine factors affecting clinical use of the targeted AV access over a variable timeframe [Time frame: postoperativ 3 -12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT06364449 · 202309052RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗