NIPH Clinical Trials Search

A study to predict the future of a shunt from its sound after surgery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Kidney Disease, End-stage Renal Disease
Date of first enrollment	05/09/2025
Target sample size	200
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Correlation between early postoperative shunt sounds and shunt blood flow volume (brachial artery flow) at 6 weeks post-surgery. Time to the onset of shunt dysfunction

Secondary Outcome

Presence or absence of shunt maturation (defined as Flow Volume > 600 ml/min in the brachial artery) at 6 weeks post-surgery. Presence or absence of FV > 400 ml/min or Resistive Index < 0.6 at 6 weeks post-surgery. Presence or absence of shunt dysfunction at 6 weeks post-surgery. Presence or absence of shunt maturation at 6 months and 1 year post-surgery. Presence or absence of FV > 400 ml/min or RI < 0.6 at 6 months and 1 year post-surgery. Correlation with shunt blood flow at 6 months and 1 year post-surgery. Presence or absence of shunt dysfunction at 6 months and 1 year post-surgery.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Patients who meet all of the following criteria will be included: 1. Patients aged 18 years or older with chronic kidney disease or end-stage renal disease (including cases of end-stage renal disease due to acute kidney injury) who undergo shunt creation surgery at each study site between the date of approval by the head of the institution and March 2028. 2. Patients who are able to attend follow-up visits at their respective study sites after enrollment. 3. Patients from whom written informed consent to participate in this study can be obtained.
Exclude criteria	Patients who meet any of the following criteria will be excluded: 1. Patients scheduled for reoperation within one week of surgery due to acute postoperative shunt stenosis or occlusion. 2. Patients who are otherwise deemed unsuitable for participation by the investigator.