We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 5, 2014
First Posted Date November 13, 2014
Last Update Posted Date March 27, 2018
Study Start Date October 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2014)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 12, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 12, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study
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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ICU patients with septic shock of medical origin
Condition
  • Sepsis
  • Septic Shock
Intervention Device: CytoSorb 300ml device (3804606CE01)
Study Groups/Cohorts
  • CytoSorb
    Patients with septic shock will get routine ICU care supported by CytoSorb® treatment.
    Intervention: Device: CytoSorb 300ml device (3804606CE01)
  • Control
    Patients with septic shock will get routine ICU care.
Publications * Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 12, 2014)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT02288975
Other Study ID Numbers CytoSorb-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Zsolt Molnár, MD, PhD, DEAA, Szeged University
Original Responsible Party Domonkos Trásy, Szeged University, Ph.D. student; Department of Anaesthesiology and Intensive Therapy
Current Study Sponsor Zsolt Molnár, MD, PhD, DEAA
Original Study Sponsor Domonkos Trásy
Collaborators Not Provided
Investigators Not Provided
PRS Account Szeged University
Verification Date March 2018