NCT02288975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

November 5, 2014

Last Update Submit

March 26, 2018

Conditions

SepsisSeptic Shock

Keywords

hemoadsorptionextracorporeal blood purificationCytoSorbhemofiltrationSIRSsepsisseptic shockmembranesICUdialysisadsorption

Outcome Measures

Primary Outcomes (2)

  • Cytokine response

    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

    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 Outcomes (2)

  • Leukocyte function

    First 48 hours of septic shock

  • Microcirculation

    First 48 hours of septic shock

Other Outcomes (3)

  • Length of intensive care unit stay,

    First 48 hours of septic shock

  • Length of hospital stay

    First 48 hours of septic shock

  • Mortality

    First 48 hours of septic shock

Study Arms (2)

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.

Interventions

CytoSorb 300ml device (3804606CE01)DEVICE
CytoSorb

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICU patients with septic shock of medical origin

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 30448517DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D. student; Department of Anaesthesiology and Intensive Therapy

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 13, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

HU(1)