Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal (PACIFIC)
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ClinicalTrials.gov Identifier: NCT03082469 |
Recruitment Status : Unknown
Verified March 2017 by Wolfgang Huber, Technische Universität München.
Recruitment status was: Not yet recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatitis, Acute SIRS | Device: CytoSorb | Phase 4 |
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.
Severity and mortality are associated to an early systemic inflammatory response syndrome (SIRS) and to septic complications at a later stage of disease.
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.
Patients with high probability of SAP (APACHE-II-score ≥10) are eligible for 7 days after the onset of pain.
The patients will be treated for 48h with two consecutive 24h sessions of cytokine absorption with the CytoSorb®-device.
All patients will be under haemodynamic Monitoring with transpulmonary thermodilution The primary endpoint is defined as an improvement of the vasopressor dependency index of ≥20% (if no vasoactive drugs are used at baseline, the cardiac power index cardiac power index (CPI) will be used as primary endpoint).
The outcome analysis will be based on comparison of the incidence of the primary endpoint in 30 Intervention patients compared to 60 matched controls.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Inflammatory cytokine removal by Cyto Sorb treatment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study. |
Estimated Study Start Date : | March 15, 2017 |
Estimated Primary Completion Date : | February 2018 |
Estimated Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
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Active Comparator: CytoSorb
CytoSorb therapy for 48h
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Device: CytoSorb
Two consecutive 24h treatments with the CytoSorb-device |
No Intervention: Matched controls
60 matched controls with SAP and transpulmonary thermodilution monitoring
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- Haemodynamics [ Time Frame: Within 48h after the onset of CytoSorb treatment ]Improvement of the vasopressor dependency index >=20%. (Improvement of cardiac power index >=20% in case of no vasopressor use at baseline)
- Mortality-1 [ Time Frame: 28 days from inclusion into the study ]28-days-mortality
- Mortality-2 [ Time Frame: From admission to the ICU until discharge or transfer from the ICU (up to one year) ]ICU-mortality
- Mortality-3 [ Time Frame: From admission to discharge from the hospital (up to one year) ]Hospital-mortality
- Inflammation [ Time Frame: Within 48h after the onset of CytoSorb treatment ]IL-6, CRP and PCT-values levels compared to before CytoSorb treatment
- Respiratory outcome [ Time Frame: Within 28 days after the onset of CytoSorb treatment ]Ventilator-free days
- Renal function and its Change over time [ Time Frame: Within 28 days after the onset of CytoSorb treatment ]Daily classification according to KDIGO; comparison vs. before Cyto Sorb treatment

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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≥ 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082469
Contact: Wolfgang Huber, Professor | ++49-89-4140-5214 | Wolfgang.Huber@tum.de | |
Contact: Tobias Lahmer, MD | ++49-89-4140-9345 | Tobias.Lahmer@mri.tum.de |
Principal Investigator: | Wolfgang Huber, Professor | II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München |
Responsible Party: | Wolfgang Huber, Professor Dr. Wolfgang Huber, Technische Universität München |
ClinicalTrials.gov Identifier: | NCT03082469 |
Other Study ID Numbers: |
PACIFIC 10-2015 |
First Posted: | March 17, 2017 Key Record Dates |
Last Update Posted: | March 17, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Severe acute pancreatitis Haemodynamic monitoring Cytokine removal Vasopressor dependency index |
Pancreatitis Pancreatic Diseases Digestive System Diseases |