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Clinical validation of Smart Flux hemodialysis filter

Clinical validation of Smart Flux hemodialysis filter made by Medica s.p.a company (Italy) with hollow fiber M-PES model, belongs to Mahan Med Meymeh Kish Company, in hemodialysis patients.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090127001598N5
Enrollment
40
Registered
2020-04-21
Start date
2019-05-22
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Hemodialysis adequacy. Encounter for adequacy testing for hemodialysis

Interventions

Intervention 1: Intervention group: Hemodialysis filter with smart flux brand from Italy Medica s.p.a with halofiber model M-PES-1.5 low and high flux from Mahan Med Meymah Kish will be used for dialy

Sponsors

Mahan Med Meymeh Kish
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Taheri

Esfahan University of Medical Sciences

sh_taheri@med.mui.ac.ir+98 31 3822 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026