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Completed

NCT Number: NCT02288975

Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

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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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb 300ml device (3804606CE01)

Device

Primary outcomes

  1. Cytokine response

    Time frame: 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

  2. Organ dysfunctions

    Time frame: 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 outcomes

  1. Leukocyte function

    Time frame: 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

  2. Microcirculation

    Time frame: First 48 hours of septic shock

    Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry

Other outcomes

  1. Length of intensive care unit stay,

    Time frame: First 48 hours of septic shock

  2. Length of hospital stay

    Time frame: First 48 hours of septic shock

  3. Mortality

    Time frame: First 48 hours of septic shock

Sponsors and collaborators

Lead sponsor

Zsolt Molnár, MD, PhD, DEAA

Other

Registry information

Official study title

The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2014
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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