|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02288975 |
|
Date of registration:
|
05/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study
|
|
Scientific title:
|
The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock |
|
Date of first enrolment:
|
October 2014 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02288975 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Hungary
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Septic Shock
|
|
Sepsis
|
|
Intervention(s)
|
|
Device: CytoSorb 300ml device (3804606CE01)
|
|
Primary Outcome(s)
|
|
Cytokine response
[Time Frame: First 48 hours of septic shock]
|
|
Organ dysfunctions
[Time Frame: First 48 hours of septic shock]
|
|
Secondary Outcome(s)
|
|
Leukocyte function
[Time Frame: First 48 hours of septic shock]
|
|
Microcirculation
[Time Frame: First 48 hours of septic shock]
|
|
Secondary ID(s)
|
|
CytoSorb-2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|