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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217095
• Other study ID #: D.Med 20-01 Convergence
• Status: Completed
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: February 22, 2022

Study information

• Verified date: February 2022
• Source: D.med Consulting GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 22, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

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.

Locations

Country	Name	City	State
North Macedonia	Special Hospital for Nephrology and Dialysis Diamed	Skopje

Sponsors (2)

Lead Sponsor	Collaborator
D.med Consulting GmbH	Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

North Macedonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Alarms	Incidence of alarms leading to end of treatment, cause identification	1 study day
Primary	Product defects	Product defects leading to end of treatment, cause identification	1 study day
Primary	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
Primary	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	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
Secondary	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
Secondary	Arterial pressure	The arterial pressure is measured in mmHg.	1 study day
Secondary	Venous pressure	The venous pressure is measured in mmHg.	1 study day
Secondary	Impeller RPM	The rotation of the impeller pump is measured in rpm.	1 study day
Secondary	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
Secondary	Dialysis Dose as Urea Reduction Ratio (URR)	The delivered dialysis dose as URR.	1 study day
Secondary	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
Secondary	Body weight change	Patient body weight change (before treatment vs. after treatment).	1 study day
Secondary	pH	The blood level of pH is measured pre/post HD. Achievement of results in laboratory acceptable ranges,	1 study day
Secondary	Bicarbonate	The blood level of Bicarbonate is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Secondary	Potassium	The blood level of Potassium is measured pre/post HD. Achievement of results in laboratory acceptable ranges,	1 study day
Secondary	Sodium	The blood level of Sodium is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Secondary	Chloride	The blood level of Chloride is measured pre/post HD. Achievement of results in laboratory acceptable ranges.	1 study day
Secondary	Free hemoglobin	The blood level of free hemoglobin (fHb measured on 30 min) to be in acceptable ranges for hemolysis	1 study day
Secondary	Anticoagulation	The total dose of anticoagulation consumption not to exceed patient treatment dose as I.U per kg	1 study day
Secondary	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