Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- D.med Consulting GmbH
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Incidence of Alarms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Convergence Dialyzer (Device)
Outcomes
Primary Outcomes
Incidence of Alarms
Time Frame: 1 study day
Incidence of alarms leading to end of treatment, cause identification
Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Time Frame: 1 study day
Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Product defects
Time Frame: 1 study day
Product defects leading to end of treatment, cause identification
Incidence of "recoverable" alarms
Time Frame: 1 study day
Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits
Secondary Outcomes
- Arterial pressure(1 study day)
- Bicarbonate(1 study day)
- Sodium(1 study day)
- Dialysis Dose as single pool Kt/V(1 study day)
- Ultrafiltration Volume(1 study day)
- pH(1 study day)
- Average Blood Flow Rate(1 study day)
- Completion Rate(1 study day)
- Venous pressure(1 study day)
- Impeller RPM(1 study day)
- Dialysis Dose as Urea Reduction Ratio (URR)(1 study day)
- Anticoagulation(1 study day)
- Clotting Score(1 study day)
- Body weight change(1 study day)
- Potassium(1 study day)
- Chloride(1 study day)
- Free hemoglobin(1 study day)