Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

• ClinicalTrials.gov Identifier: NCT02288975
• Recruitment Status: Completed
• First Posted: November 13, 2014
• Last Update Posted: March 27, 2018
• Sponsor: Zsolt Molnár, MD, PhD, DEAA
• 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

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.

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

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