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Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal (PACIFIC)

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ClinicalTrials.gov Identifier: NCT03082469
Recruitment Status : Not yet recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Detailed Description:

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 Design

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.
Anticipated Study Start Date : March 15, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: CytoSorb
CytoSorb therapy for 48h
Device: CytoSorb
Two consecutive 24h treatments with the CytoSorb-device
No Intervention: Matched controls
60 matched controls with SAP and transpulmonary thermodilution monitoring


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Mortality-1 [ Time Frame: 28 days from inclusion into the study ]
    28-days-mortality

  2. Mortality-2 [ Time Frame: From admission to the ICU until discharge or transfer from the ICU (up to one year) ]
    ICU-mortality

  3. Mortality-3 [ Time Frame: From admission to discharge from the hospital (up to one year) ]
    Hospital-mortality

  4. Inflammation [ Time Frame: Within 48h after the onset of CytoSorb treatment ]
    IL-6, CRP and PCT-values levels compared to before CytoSorb treatment

  5. Respiratory outcome [ Time Frame: Within 28 days after the onset of CytoSorb treatment ]
    Ventilator-free days

  6. 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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
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

Sponsors and Collaborators
Technische Universität München
CytoSorbents Europe GmbH
Investigators
Principal Investigator: Wolfgang Huber, Professor II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
More Information

Responsible Party: Wolfgang Huber, Professor Dr. Wolfgang Huber, Technische Universität München
ClinicalTrials.gov Identifier: NCT03082469     History of Changes
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
Plan Description: n.a.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wolfgang Huber, Technische Universität München:
Severe acute pancreatitis
Haemodynamic monitoring
Cytokine removal
Vasopressor dependency index

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases