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Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Szeged University
Sponsor:
Information provided by (Responsible Party):
Domonkos Trásy, Szeged University
ClinicalTrials.gov Identifier:
NCT02288975
First received: November 5, 2014
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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 Intervention
Sepsis
Septic Shock
Device: CytoSorb 300ml device (3804606CE01)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Szeged University:

Primary Outcome Measures:
  • 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

  • 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:
  • 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

  • Microcirculation [ Time Frame: First 48 hours of septic shock ]
    Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry


Other Outcome Measures:
  • Length of intensive care unit stay, [ Time Frame: First 48 hours of septic shock ]
  • Length of hospital stay [ Time Frame: First 48 hours of septic shock ]
  • Mortality [ Time Frame: First 48 hours of septic shock ]

Estimated Enrollment: 20
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02288975

Contacts
Contact: Domonkos Trásy, MD +36 62 - 545 168 trasydom@gmail.com

Locations
Hungary
Department of Anaesthesiology and Intensive Therapy Recruiting
Szeged, Csongrád, Hungary, H-6725
Contact: Domonkos Trásy, MD    +36 62 - 545 168    trasydom@gmail.com   
Sponsors and Collaborators
Domonkos Trásy
  More Information

Responsible Party: Domonkos Trásy, Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University
ClinicalTrials.gov Identifier: NCT02288975     History of Changes
Other Study ID Numbers: CytoSorb-2014
Study First Received: November 5, 2014
Last Updated: March 8, 2017

Keywords provided by Szeged University:
CytoSorb
hemoadsorption
extracorporeal blood purification
hemofiltration
SIRS
sepsis
septic shock
membranes
ICU
dialysis
adsorption

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Shock
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on March 30, 2017