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Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

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ClinicalTrials.gov Identifier: NCT02288975
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Zsolt Molnár, MD, PhD, DEAA, Szeged University

Study Description
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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.

Condition or disease Intervention/treatment
Sepsis Septic Shock Device: CytoSorb 300ml device (3804606CE01)

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock
Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
CytoSorb
Patients with septic shock will get routine ICU care supported by CytoSorb® treatment.
 Device: CytoSorb 300ml device (3804606CE01)
Control
Patients with septic shock will get routine ICU care.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patients with septic shock of medical origin
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288975


Locations
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Hungary
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád, Hungary, H-6725
Sponsors and Collaborators
Zsolt Molnár, MD, PhD, DEAA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zsolt Molnár, MD, PhD, DEAA, Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University
ClinicalTrials.gov Identifier: NCT02288975    
Other Study ID Numbers: CytoSorb-2014
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Keywords provided by Zsolt Molnár, MD, PhD, DEAA, Szeged University:
hemoadsorption
extracorporeal blood purification
CytoSorb
hemofiltration
SIRS
sepsis
 septic shock
membranes
ICU
dialysis
adsorption
Additional relevant MeSH terms:
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Shock, Septic
Shock
Sepsis
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes