JRCT ID: jRCTs032250362
Registered date:16/09/2025
Clinical Effectiveness of Dual-Clamp Single-Needle Dialysis
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic renal failure |
| Date of first enrollment | 16/09/2025 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | The objective of this study is to evaluate the difference in dialysis efficiency between the standard single-needle dialysis method and a modified approach involving the use of a clamp for the return line, with the aim of controlling recirculation (double-clamp method). |
Outcome(s)
| Primary Outcome | Kt/v calculated from pre- and post-dialysis BUN |
|---|---|
| Secondary Outcome | Predicted blood flow rate Post-dialysis serum potassium and bicarbonate levels Imbalance syndrome Observation of hypokalemia and hyperbicarbonemia Patient complaints, physical condition observation Failure of blood circuits with clamps for debridement lines Failure of equipment for dialysis All illnesses, etc. arising from this study |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | (1)Patients requiring haemodialysis (2)Patients on single-needle dialysis for more than one consecutive week (3)If the Principal Investigator determines that there is no medical detriment to switching to a single needle. (4)Patients whose mode of treatment is dialysis (HD) or intermittent replacement haemodiafiltration (IHDF) (5) Patients who have obtained written consent for participation in this study from themselves or their surrogate. (6)Men and women who are 20 years of age or older at the time consent is obtained. |
| Exclude criteria | (1)Patients who will need to undergo other haemodialysis therapies such as peritoneal dialysis during the study period, which may affect the assessment of the dialysis index. (2)Patients whose mode of treatment is hemodiafiltration dialysis (HDF) or hemofiltration (HF) or Extracorporeal ultrafiltration method (ECUM) (3)Patients who are unable to perform single needle dialysis consistently due to poor blood remov or poor blood return. (4)Patients deemed by the principal investigator to be inappropriate for this study |
Related Information
| Primary Sponsor | Shinji Ako |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Suzuki Kojiro |
| Address | 4417-180,Hata, Matsumoto City, Nagano Prefecture Nagano Japan 390-1401 |
| Telephone | +81-263-92-3027 |
| koujirou.08@gmail.com | |
| Affiliation | Matsumoto City Hospital |
| Scientific contact | |
| Name | Ako Shinji |
| Address | 4417-180,Hata, Matsumoto City, Nagano Prefecture Nagano Japan 390-1401 |
| Telephone | +81-263-92-3027 |
| 999806@mt-hsp.jp | |
| Affiliation | Matsumoto City Hospital |