Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.

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Detailed Description

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Conditions

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Sepsis Septic Shock

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CytoSorb

Patients with septic shock will get routine ICU care supported by CytoSorb® treatment.

CytoSorb 300ml device (3804606CE01)

Intervention Type DEVICE

Control

Patients with septic shock will get routine ICU care.

No interventions assigned to this group

Interventions

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CytoSorb 300ml device (3804606CE01)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 3 ng/ml
* Invasive hemodynamic monitoring
* Written informed content

Exclusion Criteria

* Patients under 18 years
* Pregnancy (bHCG test positivity)
* Surgical intervention in context with the septic insult
* New York Heart Association IV heart failure
* Acute coronary syndrome
* Need for acute or chronic hemodialysis
* Acute haematological malignancies
* Cardiogenic shock
* Post cardiopulmonary resuscitation care
* Immunosuppression, systemic steroid therapy (\>10mg prednisolon/day)
* Human immunodeficiency virus infection (HIV) and active AIDS
* Patients with donated organs
* Thrombocytopenia (\<20.000/ml)
* More than 10%-of body surface area with third degree burn

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No