Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

Completed

• Conditions: Septic Shock; Sepsis
• Interventions: Device: CytoSorb 300ml device (3804606CE01)

• Registration Number: NCT02288975
• Lead Sponsor: Zsolt Molnár, MD, PhD, DEAA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CytoSorb	CytoSorb 300ml device (3804606CE01)	Patients with septic shock will get routine ICU care supported by CytoSorb® treatment.

Primary Outcome Measures

Name	Time	Method
Cytokine response	First 48 hours of septic shock	Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α
Organ dysfunctions	First 48 hours of septic shock	Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count)

Secondary Outcome Measures

Name	Time	Method
Leukocyte function	First 48 hours of septic shock	Leukocyte function: heterogeneity of leukocyte cell population in the bloodstream, T-cell activation and apoptosis, leukocyte inflammatory markers expression
Microcirculation	First 48 hours of septic shock	Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Szeged, Csongrád, Hungary