Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

Hemodialysis Complication Clinical Trial

Official title:

Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168539
• Other study ID #: CIV-20-02-031667
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: January 2024
• Source: Umeå University
• Contact: Ulf Forsberg, MD, PhD
• Phone: +46907850000
• Email: ulf.forsberg[@]regionvasterbotten.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use.

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.

Description:

During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented in Europe, USA and India. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Accepted are all patients performing chronic HD due to End Stage renal disease of any reason:

• 18 years and older

• accept, by consent, to participate in the study

• both genders,

• any ethnicity

Exclusion Criteria:

Patients that are expected not to fulfil a whole series of two dialysis within the study such as those:

• 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).

Related Conditions & MeSH terms

• Air Embolism
• Embolism
• Embolism, Air
• Extracorporeal Circulation; Complications
• Hemodialysis Complication

Intervention

Other:
• 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

Locations

Country	Name	City	State
Sweden	Region Vasterbotten, Skelleftea Sjukhus, Dialysen	Skelleftea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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.1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of change in air micro bubbles during hemodialysis	Numbers of air micro bubbles (diameter sizes from 20-500µm diameter) are counted at inlet and outlet of the air trap with parallel probes using ultrasound GAMPT 200 device during 30minutes of HD. A calculation clarifies change in percentage of outlet versus inlet amount/size of microbubble air return into the return bloodline that is connected to the return needle placed in the vein of the patient. The size in diameter and numbers within the dialysis time/30 minutes of HD are given.	1 year
Secondary	Comparison of change in air micro bubbles for hemodialysis versus hemodiafiltration	The Investigator aims to compare the microbubble reduction of the air traps also between the hemodialysis versus hemodiafiltration if the specific patient performs this dialysis under normal circumstances.	1 year
Secondary	adverse events	If a patient experience adverse events these will be reported	1 year