Apheresis based treatment of sepsis

Withdrawn

Conditions: blood poisoning
10038158
10004018

Registration Number: NL-OMON45881

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Reduction of RBC-pathogen complexes after 1 session of apheresis with<br /><br>processing 1.5 times the patients total blood volume which is calculated based<br /><br>on Nadlers formula.<br /><br>- Haematological parameters, such as RBC, platelet and leukocyte counts,<br /><br>before and after apheresis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Vital parameters during apheresis (blood pressure, saturation, pulse, heart<br /><br>rhythm)<br /><br>- total Ca, ionized Ca, lactate, Mg,<br /><br>- SOFA score day of inclusion and day after inclusion<br /><br>- Outcome (28 day mortality)<br /><br>- Duration of ICU stay<br /><br>- Duration of hospital stay<br /><br>- Bloodgas analysis</p><br>