SIRS Clinical Trial
— PACIFICOfficial title:
Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.
Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related
to the development of SIRS and consecutive organ failures. Due to the lack of a causative
therapy except the removal of bile duct stones, therapy is predominantly symptomatic.
With regard to a marked inflammatory response ("cytokine storm") during the early phase of
SAP extracorporeal cytokine removal is a promising therapeutic approach.
This prospective case control study investigates the impact of early extracorporeal cytokine
adsorption with the CytoSorb®-device on haemodynamics (primary endpoint) and several
secondary outcomes.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | July 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Proven acute pancreatitis: - typical pain - at least 3-fold increase in serum lipase - onset of pain within 7 days before inclusion AND - APACHE-II =10 AND - =1 criterion of "severe sepsis" AND - Haemodynamic monitoring with transpulmonary thermodilution AND - = 1 marker of poor prognosis of acute pancreatitis: - Haematocrit > 44% (men), >40% (women) - Blood glucose > 125 mg/dL - C-reactive protein (CRP) > 10mg/dL - Computed tomography score category C-E - Age >55 years - Leukocytes >16 G/L - Glutamate oxaloacetate transferase (GOT) >250 U/L - Lactate dehydrogenase (LDH) >350 U/L - Calcium <2,0mmol/L Exclusion Criteria: - pregnancy - lack of informed consent of patient or representative - pre-existing disease with life expectancy <3 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München | CytoSorbents Europe GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Haemodynamics | Improvement of the vasopressor dependency index >=20%. (Improvement of cardiac power index >=20% in case of no vasopressor use at baseline) | Within 48h after the onset of CytoSorb treatment | |
Secondary | Mortality-1 | 28-days-mortality | 28 days from inclusion into the study | |
Secondary | Mortality-2 | ICU-mortality | From admission to the ICU until discharge or transfer from the ICU (up to one year) | |
Secondary | Mortality-3 | Hospital-mortality | From admission to discharge from the hospital (up to one year) | |
Secondary | Inflammation | IL-6, CRP and PCT-values levels compared to before CytoSorb treatment | Within 48h after the onset of CytoSorb treatment | |
Secondary | Respiratory outcome | Ventilator-free days | Within 28 days after the onset of CytoSorb treatment | |
Secondary | Renal function and its Change over time | Daily classification according to KDIGO; comparison vs. before Cyto Sorb treatment | Within 28 days after the onset of CytoSorb treatment |
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