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Clinical Effectiveness of Dual-Clamp Single-Needle Dialysis

Development of a blood removal line clamp to suppress recirculation during single needle dialysis in hemodialysis treatment and study of its clinical efficacy when attached to blood circuits and dialysis machines (dual clamp single needle dialysis).

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250362
Enrollment
10
Registered
2025-09-16
Start date
2025-09-16
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic renal failure Hemodialysis

Interventions

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

Sponsors

Shinji Ako
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Kt/v calculated from pre- and post-dialysis BUN

Secondary

MeasureTime frame
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

Contacts

Public ContactSuzuki Kojiro

Matsumoto City Hospital

koujirou.08@gmail.com+81-263-92-3027

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026