Clinical trial NCT05217095: Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
Official title: Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Lead sponsor: D.med Consulting GmbH
Sponsor class: INDUSTRY
Collaborators: name: Fresenius Medical Care Deutschland GmbH
First posted: 2022-02-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Alarms
timeFrame: 1 study day
measure: Product defects
timeFrame: 1 study day
measure: Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
timeFrame: 1 study day
measure: Incidence of "recoverable" alarms
timeFrame: 1 study day
Secondary outcomes:
measure: Completion Rate
timeFrame: 1 study day
measure: Average Blood Flow Rate
timeFrame: 1 study day
measure: Arterial pressure
timeFrame: 1 study day
measure: Venous pressure
timeFrame: 1 study day
measure: Impeller RPM
timeFrame: 1 study day
measure: Dialysis Dose as single pool Kt/V
timeFrame: 1 study day
measure: Dialysis Dose as Urea Reduction Ratio (URR)
timeFrame: 1 study day
measure: Ultrafiltration Volume
timeFrame: 1 study day
measure: Body weight change
timeFrame: 1 study day
measure: pH
timeFrame: 1 study day
measure: Bicarbonate
timeFrame: 1 study day
measure: Potassium
timeFrame: 1 study day
measure: Sodium
timeFrame: 1 study day
measure: Chloride
timeFrame: 1 study day
measure: Free hemoglobin
timeFrame: 1 study day
measure: Anticoagulation
timeFrame: 1 study day
measure: Clotting Score
timeFrame: 1 study day
Other outcomes:
Locations:
city: Skopje
country: North Macedonia
facility: Special Hospital for Nephrology and Dialysis Diamed
Study officials:
affiliation: Specialized Hospital for Nephrology and Dialysis Diamed
name: Elena Babalj-Banskolieva, Dr.
role: PRINCIPAL_INVESTIGATOR
References: