Pilot Trial on the Combined Therapy of Cytokine Filtration and Granulocyte/Monocyte Adsorption in Sepsis

Not Applicable

• Conditions: A41.8; R57.2; Other specified sepsis; Septic shock

• Registration Number: DRKS00007559
• Lead Sponsor: eXcorLab GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Study Completion: 2016-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Severe sepsis or septic shock,
- Acute, septic renal failure and indication for renal replacement therapy,
- Age =18 years,
- Written informed consent of the patient or next of kin or legally authorized person

Exclusion Criteria

- Pregnant or breast-feeding women,
- Age > 90 years,
- bleeding risk due to underlying disease or recently performed surgery,
- known allergies to components of the extracorporeal therapy,
- Contraindications to heparin for anticoagulation including heparin induced thrombocytopenia Type II
- previous severe sepsis during the hospital stay (re-Sepsis”),
- very poor prognosis (life expectancy < 6 months) due to concomitant disease (except severe sepsis or septic shock),
- Aplasia,
- currently on chemotherapy.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at day 90

Secondary Outcome Measures

Name	Time	Method
1. Mortality at day 28<br>2. Length of stay on Intensive Care Unit<br>3. median SOFA- and APACHE II- (Sub-)Scores after 5 and 28 days<br>4. Length of stay in Hospital after study start<br>5. Daily urine output<br>6. Length of anuria until hospital dismission<br>7. Frequency and length of ventilator therapy until day 28<br>8. Vasopressor drug requirements until day 28<br>9. Length of renal replacement therapy until day 90<br>10. Course of defined laboratory parameters<br>11. Feasability of study therapy / study targets