Evaluation of the air pants on hemodialysis hypotension

JRCT ID: jRCTs062210020

Registered date:02/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypotension during hemodialysis
• Date of first enrollment: 02/07/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): An evaluation whether dialysis hypotension and the water removal rate can be improved by compressing the lower body with the air pants device.

Outcome(s)

• Primary Outcome: 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 Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Yamasaki Fumiyasu
• Source(s) of Monetary Support: Kochi Prefecture