Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

March 26, 2018 updated by: Zsolt Molnár, MD, PhD, DEAA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Csongrád
      • Szeged, Csongrád, Hungary, H-6725
        • Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU patients with septic shock of medical origin

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First 48 hours of septic shock
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)
First 48 hours of septic shock

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First 48 hours of septic shock
Microcirculation
Time Frame: First 48 hours of septic shock
Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry
First 48 hours of septic shock

Other Outcome Measures

Outcome Measure
Time Frame
Length of intensive care unit stay,
Time Frame: First 48 hours of septic shock
First 48 hours of septic shock
Length of hospital stay
Time Frame: First 48 hours of septic shock
First 48 hours of septic shock
Mortality
Time Frame: First 48 hours of septic shock
First 48 hours of septic shock

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zsolt Molnár, MD, PhD, DEAA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CytoSorb-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on CytoSorb 300ml device (3804606CE01)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe