Clinical validation of Smart Flux hemodialysis filter

Phase 3

• Conditions: Hemodialysis adequacy.; Encounter for adequacy testing for hemodialysis; Z49.31

• Registration Number: IRCT20090127001598N5
• Lead Sponsor: Mahan Med Meymeh Kish

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

To be on hemodialysis more than 3 months
Age more than 20 year and less than 75 year.
Have stable clinical and laboratory condition, (Corrected Ca>8mg%, K=5.5 Hct>20%).
Scheduled regular 3 times weekly hemodialysis program.
Have stable vascular access.
Have stable blood pressure.
Have stable hemodynamic and cardiovascular condition, (for example no heart attack or cerebrovascular events in last three months).
Have no acute infection or malignant tumors
Have no severe anemia ( hematocrit more than 20%)
Patient give informed consent to participate in this clinical trial

Exclusion Criteria

Patient has uncontrolled high or low blood pressure (systolic BP less than 90 mmHg or more than 180 mmHg at the start of hemodialysis.
For any reason the patient needs for blood transfusion.
For any reason the patient needs hospitalization.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodialysis adequacy. Timepoint: Before starting intervention and at the end of each phase. Method of measurement: laboratory measurement of BUN before and after the dialysis and calculating URR and KT/V.

Secondary Outcome Measures

Name	Time	Method
Hypotension during and at the end of hemodialysis. Timepoint: At the start of each hemodialysis session and then every hour and at the completion of the hemodialysis session. Method of measurement: Measurement of systolic and diastolic blood pressure by sphygmomanometer.;Itching during hemodialysis. Timepoint: During each hemodialysis session. Method of measurement: Observe and record it by the responsible nurse.;Clot formation in hemodialysis filter fibers during each hemodialysis session. Timepoint: During each hemodialysis session. Method of measurement: Observe and record it by the responsible nurse.;Shortness of breath. Timepoint: ??During each hemodialysis session. Method of measurement: Observed by the nurse in charge and measurement of blood oxygen saturation percentage by pulse oximeter.