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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
Sponsor:
Collaborator:
CytoSorbents Europe GmbH
Information provided by (Responsible Party):
Wolfgang Huber, Technische Universität München

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date March 17, 2017
Estimated Study Start Date  ICMJE March 15, 2017
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal
Official Title  ICMJE Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Pancreatitis, Acute
  • SIRS
Intervention  ICMJE Device: CytoSorb
Two consecutive 24h treatments with the CytoSorb-device
Study Arms  ICMJE
  • Active Comparator: CytoSorb
    CytoSorb therapy for 48h
    Intervention: Device: CytoSorb
  • No Intervention: Matched controls
    60 matched controls with SAP and transpulmonary thermodilution monitoring
Publications * Huber W, Algül H, Lahmer T, Mayr U, Lehmann M, Schmid RM, Faltlhauser A. Pancreatitis cytosorbents (CytoSorb) inflammatory cytokine removal: A Prospective Study (PACIFIC). Medicine (Baltimore). 2019 Jan;98(4):e13044. doi: 10.1097/MD.0000000000013044.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082469
Other Study ID Numbers  ICMJE PACIFIC 10-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: n.a.
Responsible Party Wolfgang Huber, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE CytoSorbents Europe GmbH
Investigators  ICMJE
Principal Investigator: Wolfgang Huber, Professor II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
PRS Account Technische Universität München
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP