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Evaluation of the air pants on hemodialysis hypotension

Evaluation of arterial pressure control device with air-pants for treatment of hypotension during hemodialysis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062210020
Enrollment
20
Registered
2021-07-02
Start date
2021-07-27
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

Hypotension during hemodialysis

Interventions

An evaluation whether dialysis hypotension and the water removal rate can be improved by compressing the lower body with the air pants device.

Sponsors

Yamasaki Fumiyasu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Written consent was obtained from the patient herself or himself for participation. 2) Age of consent acquisition date is 20 years or older (gender does not matter) 3) On dialysis. 4) During dialysis (12 times) during the past month, it was confirmed that the target water removal amount could not be achieved and/or the dialysis time was extended because the systolic blood pressure dropped to less than 100 mmHg.

Exclusion criteria

Exclusion criteria: 1) Patients with arteriosclerosis obliterans of the lower extremities 2) Patients with lower extremity vein thrombosis 3) Pregnant woman 4) Patients disqualified by a doctor

Design outcomes

Primary

MeasureTime frame
Presence or absence of improvement in the water removal rate "water removal rate after blood pressure decrease", from the time of blood pressure decrease to the 4th hour of dialysis in each trial.

Secondary

MeasureTime frame
(1) Change in water removal amount from baseline after lowering blood pressure (2) Changes in the amount of water removed and the rate of water removed from the baseline date at the 4th hour of dialysis and at the end of dialysis if dialysis is extended. (3) Change in water removal time from baseline date (4) Decrease in blood pressure and change in rate of decrease in blood pressure from baseline date (5) Changes in symptoms due to hypotension from baseline date. (6) Equipment safety evaluation.

Contacts

Public ContactFumiyasu Yamasaki

Kochi Medical School Hospital

yamasaki-f@kochi-u.ac.jp+81-88-866-5811

Outcome results

None listed

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