Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine

The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Device: Convergence Dialyzer

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• North Macedonia
  • Skopje, North Macedonia, 1000
    • Special Hospital for Nephrology and Dialysis Diamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be up to 18-85 years
• Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment
• Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges.
• Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia <25% in the last 3 Months
• Well-functioning AVF vascular access: access recirculation ≤10%
• No coagulation disorders and anticoagulant therapy
• Patients must be using a similar size dialyzer as Convergence dialyzer
• Signed Inform consent form.

Exclusion Criteria:

• Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment
• Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study.
• History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment.
• Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
• Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
• Temporary excluded will be patients with increased body temperature due to some infective disease, dehydration, diarrhea, hyperglycemia,
• Severe bleeding, or history or evidence of bleeding diathesis or coagulopathy with the risk of bleeding or have to put on dialysis without anticoagulant.
• Using temporary or permanent dialysis catheter
• Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator.
• Known pregnancy and lactating without pregnancy test
• Patient has known allergy or hypersensitivity reaction to dialyzer membrane or other disposable
• Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage
• Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator
• Any other conditions at the discretion of investigator not suitable for patients to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Interventional Group; Each patient will be treated for one session of dialysis after enrolled. Each of them will have only one treatment in the middle of the week (Wednesday or Thursday). The patients will be treated using 4008A dialysis machines in combination with a sidecar and the convergence dialyzer as investigational devices.Each patient will be treated according their regular treatment and laboratory analysis will be taken. The blood level of free hemoglobin ( fHb ) will be taken on 30 min by use of HemoCue device. ACT time will be measured on 15 min and for that 0.5 ml blood from venous line will be taken.

Device: Convergence Dialyzer; The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Alarms	Incidence of alarms leading to end of treatment, cause identification	1 study day
Product defects	Product defects leading to end of treatment, cause identification	1 study day
Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect	Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect	1 study day
Incidence of "recoverable" alarms	Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits	1 study day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	The completion rate of a dialysis session according to prescription. The study is considered to be successful, if at least 8 patients reach the effective dialysis time.	1 study day
Average Blood Flow Rate	The average blood flow rate is measured during the dialysis treatment. Maintenance of preset blood flow rates throughout the dialysis in at least 8 out of 10 patients	1 study day
Arterial pressure	The arterial pressure is measured in mmHg.	1 study day
Venous pressure	The venous pressure is measured in mmHg.	1 study day
Impeller RPM	The rotation of the impeller pump is measured in rpm.	1 study day
Dialysis Dose as single pool Kt/V	The delivered dialysis dose as single-pool Kt/V. Achievement of a spKt/V > 1.4 in at least 8 out of 10 patients.	1 study day
Dialysis Dose as Urea Reduction Ratio (URR)	The delivered dialysis dose as URR.	1 study day
Ultrafiltration Volume	Total ultrafiltration volume (ml). Achievement of preset total ultrafiltration volume (ml) to reach dry weight target in at least 8 out of 10 patients.	1 study day
Body weight change	Patient body weight change (before treatment vs. after treatment).	1 study day
pH	The blood level of pH is measured pre/post HD. Achievement of results in laboratory acceptable ranges,	1 study day
Bicarbonate	The blood level of Bicarbonate is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Potassium	The blood level of Potassium is measured pre/post HD. Achievement of results in laboratory acceptable ranges,	1 study day
Sodium	The blood level of Sodium is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Chloride	The blood level of Chloride is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Free hemoglobin	The blood level of free hemoglobin (fHb measured on 30 min) to be in acceptable ranges for hemolysis	1 study day
Anticoagulation	The total dose of anticoagulation consumption not to exceed patient treatment dose as I.U per kg	1 study day
Clotting Score	The clotting score of dialyzer(visual check, using common scale for dialyzer study); No visible thrombosed fibers; A few visible thrombosed fibers; Moderately visible thrombosed fibers; Many visible thrombosed fibers; Completely visible thrombosed fibers So the score goes from 1 (good) to 5 (bad).	1 study day

Collaborators and Investigators

• Sponsor: D.med Consulting GmbH
• Collaborators: Fresenius Medical Care Deutschland GmbH
• Investigators: Principal Investigator: Elena Babalj-Banskolieva, Dr., Specialized Hospital for Nephrology and Dialysis Diamed

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D.Med 20-01 Convergence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No