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

JRCT ID: jRCTs032200024

Registered date:27/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic dialysis patients, vascular access therapy
• Date of first enrollment: 07/07/2022
• Target sample size: 5
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

The 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 Outcome

Diagnosis 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1 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

• Primary Sponsor: Yamagata Kunihiro