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Apheresis based treatment of sepsis

Apheresis based treatment of sepsis - ASSIST

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45881
Enrollment
15
Registered
2019-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Volunteers: - >18 years old - Healthy male volunteer - Meet eligibility criteria for donating whole blood in the Netherlands - Informed consent;Patients: - ICU patient recovering from sepsis, who have detectable RBC-pathogen complexes in their blood. - * 18 years old - Existing vascular access preferably a double lumen dialysis catheter - Informed consent

Exclusion criteria

Exclusion criteria: Volunteers: - Any abnormal test result during the screening prior to inclusion of the study (medical history, physical examination, and blood examination) - History of drugs or alcohol abuse - Any present medication use on prescription - Participation in any other intervention study during the course of this study;Patients: - Hemodynamic instability as defined by requiring >0.1 mcg/kg/minute of norepinephrine to reach a MAP of > 60 mmHg. - Active bleeding as assessed by the treating physician - Haematological disorders. - Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
- Reduction of RBC-pathogen complexes after 1 session of apheresis with processing 1.5 times the patients total blood volume which is calculated based on Nadlers formula. - Haematological parameters, such as RBC, platelet and leukocyte counts, before and after apheresis

Secondary

MeasureTime frame
- Vital parameters during apheresis (blood pressure, saturation, pulse, heart rhythm) - total Ca, ionized Ca, lactate, Mg, - SOFA score day of inclusion and day after inclusion - Outcome (28 day mortality) - Duration of ICU stay - Duration of hospital stay - Bloodgas analysis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)