NIPH Clinical Trials Search

JRCT ID: jRCTs032200024

Registered date:27/04/2020

A pilot study for chronic dialysis patients: Safety study using CV port and new needle for blood return of chronic dialysis patients

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedchronic dialysis patients, vascular access therapy
Date of first enrollment07/07/2022
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)Place the CV port in either the left or right subclavian vein. The newly developed 18-gauge puncture needle is used for blood return. The original vascular access is used for blood removal.


Primary OutcomeThe blood return success rate of 75% using CVport: The blood return success rate per individual participants, blood return success rate (%) = [CV port blood return time / ( CV port blood return time plus blood return time other than CV port)] times 100
Secondary OutcomeDiagnosis parameters such as patient outcome, dialysis efficiency, blood pressure, dialysis hour.Record of flow volume and observation and examination of needle lume after use. Safety endpoint, adverse events such as incidence of CV port and vascular access infection, other infections, vascular access outcome, blood data. Malfunction of CV port and needle in use. Up to maximum one year after one month of the primary endpoint, if the CV port is kept in place and dialysis is performed, a follow-up survey will be observed the same issues.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Chronic dialysis patients at participating institutions of this study 2) Patients who have difficulty in puncturing vascular access of arteriovenous fistula shunt, artificial graft, subcutaneously fixed superficial artery, or the autologous blood vessels, and are unable to secure an appropriate blood return, or can puncture but have insufficient blood return. 3) Men and women over 20 years old with written informed consent
Exclude criteria1 participant allergic to CV port 2 If there is an infection at the CV port insertion site or if there is a suspicion of infection 3 participant with a cardiac pacemaker or ICD (implantable cardioverter defibrillator) in progress 4 participants who are judged inappropriate by the researcher 5 participants whose mean blood flow in maintenance dialysis are more than 210ml / min for 1 week just before study participation

Related Information


Public contact
Name Hirayasu Kai
Address 2-1-1 Amakubo Tsukuba Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3202
Affiliation University of Tsukuba Hospital
Scientific contact
Name Kunihiro Yamagata
Address 2-1-1 Amakubo Tsukuba Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3202
Affiliation University of Tsukuba Hospital