Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis
NCT ID: NCT06168539
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-05-11
2024-12-10
Brief Summary
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The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008).
Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient was included to make two paired series. A safety committee evaluates if significantly worse outcome appears especially with the Emboless, to stop the study.
During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps.
Monitoring of the study is performed.
Detailed Description
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The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008).
Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient is included to make two paired series. A maximum of 30 patients are planned. Each with 2 series of each two different sets of air traps that would give a total of 120 dialyses. A safety committee evaluates if significantly worse outcome appears especially with the Emboless.
During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps.
Monitoring of the study is performed.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Standard
A regular standard dialysis is performed and held as active comparator for analysis
Standard
Standard dialysis set is used as comparative
Emboless
Emboless tubing set is part of the extracorporeal venous bloodline instead of the venous chamber by Fresenius (see standard above).
For more information see reference Jonsson et al 2023- mentioned in references.
Emboless
Emboless has the US patent number 8894749 is compared to standard dialysis See also reference Jonsson et al 2023 referred to in the main text.
Interventions
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Emboless
Emboless has the US patent number 8894749 is compared to standard dialysis See also reference Jonsson et al 2023 referred to in the main text.
Standard
Standard dialysis set is used as comparative
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* accept, by consent, to participate in the study
* both genders,
* any ethnicity
Exclusion Criteria
* who suffer from active cancer or severe infection, cachexia or are planned for kidney transplantation close to the study period.
* patients that by any reason are considered inappropriate by the principal investigator, such as patients that experience severe hypotensive episodes during standard dialysis.
Home-haemodialysis treatments and self-care dialysis treatments are not included in the study. If such patient accepts to participate in the study, he/she has to adapt to study criteria (assisted treatment).
18 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Ulf Forsberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Vasterbotten Skelleftea Hospital, Sweden
Locations
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Region Vasterbotten, Skelleftea Sjukhus, Dialysen
Skellefteå, , Sweden
Countries
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References
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Stegmayr BG. Sources of Mortality on Dialysis with an Emphasis on Microemboli. Semin Dial. 2016 Nov;29(6):442-446. doi: 10.1111/sdi.12527. Epub 2016 Aug 16.
Stegmayr B. Air contamination during hemodialysis should be minimized. Hemodial Int. 2017 Apr;21(2):168-172. doi: 10.1111/hdi.12474. Epub 2016 Aug 30.
Matsuda K, Fissell R, Ash S, Stegmayr B. Long-Term Survival for Hemodialysis Patients Differ in Japan Versus Europe and the USA. What Might the Reasons Be? Artif Organs. 2018 Dec;42(12):1112-1118. doi: 10.1111/aor.13363. Epub 2018 Nov 11. No abstract available.
Forsberg U, Jonsson P, Stegmayr B. Air contamination during medical treatment results in deposits of microemboli in the lungs: An autopsy study. Int J Artif Organs. 2019 Sep;42(9):477-481. doi: 10.1177/0391398819840363. Epub 2019 Apr 11.
Forsberg U, Jonsson P, Stegmayr B. Microemboli induced by air bubbles may be deposited in organs as a consequence of contamination during medical care. Clin Kidney J. 2022 Oct 6;16(1):159-166. doi: 10.1093/ckj/sfac217. eCollection 2023 Jan.
Jonsson P, Stegmayr C, Stegmayr B, Forsberg U. Venous chambers in clinical use for hemodialysis have limited capacity to eliminate microbubbles from entering the return bloodline: An in vitro study. Artif Organs. 2023 Jun;47(6):961-970. doi: 10.1111/aor.14495. Epub 2023 Jan 10.
Other Identifiers
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CIV-20-02-031667
Identifier Type: -
Identifier Source: org_study_id