Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288975
• Other study ID #: CytoSorb-2014
• Status: Completed
• First received: November 5, 2014
• Last updated: March 26, 2018
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Systemic Inflammatory Response Syndrome

Intervention

Device:
• CytoSorb 300ml device (3804606CE01)

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Zsolt Molnár, MD, PhD, DEAA

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of intensive care unit stay,		First 48 hours of septic shock
Other	Length of hospital stay		First 48 hours of septic shock
Other	Mortality		First 48 hours of septic shock
Primary	Cytokine response	Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- a	First 48 hours of septic shock
Primary	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	Leukocyte function	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
Secondary	Microcirculation	Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry	First 48 hours of septic shock