Comparison of efficacy and safety between plastic needle and metal needle in hemodialysis treatment

A randomized, open-label study to evaluate the efficacy and safety of plastic cannula compared with metal needle in incident hemodialysis patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003745

Enrollment

Registered

2019-04-12

Start date

2018-01-09

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Hemodialysis treatment needs to puncture two needles into vascular access. Patient&#39

s blood comes from one needle, and pass through the dialyzer, and then return to the vascular access via the other needle. In this study, incident hemodialysis patients will be divided into two groups

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Incident hemodialysis patients who newly created AVFs - Patients who can use low-dose aspirin, as guidelines recommend

Exclusion criteria

Exclusion criteria: Patients with long-standing use of steroid or immunosuppressive agents or pre-existing skin diseases were all excluded. Patients who cannot meet our Doppler criteria at needling point: adequate fistula size = 0.5 cm, blood flow = 500 mL/min, depth from skin < 1.0 cm and presence of intact AVF configuration. Patients who doesn't want

Design outcomes

Primary

Measure	Time frame
Primary endpoint is an initial cannulation failure, defined as the failure of successful completion of three consecutive dialysis sessions with adequate blood flow rates. .	—

Secondary

Measure	Time frame
Complications related to needle cannulation (hematoma, infiltration, inadequate blood flow);the needed time until three consecutive successful cannulation and dialysis sessions;degree of pain felt by patients;degree of cannulation difficulty;hemodialysis adequacy	—

Countries

Korea, Republic of

Contacts

Public ContactJwa-Kyung Kim

Hallym University Medical Center

jwa816@naver.com+82-31-380-3720

Outcome results