Clinical trial NCT06364449: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study
Official title: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Decision Tree Analysis
Keywords: Arteriovenous Fistula
AV graft
Hemodialysis
decision tree analysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Primary outcomes:
measure: predicted AV access choices
timeFrame: postoperativ 3 -12 months
Secondary outcomes:
measure: to determine factors affecting clinical use of the targeted AV access over a variable timeframe
timeFrame: postoperativ 3 -12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Yang Chan, phd
role: PRINCIPAL_INVESTIGATOR
References: