NCT03082469

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

January 13, 2017

Last Update Submit

March 10, 2017

Conditions

Pancreatitis, AcuteSIRS

Keywords

Severe acute pancreatitisHaemodynamic monitoringCytokine removalVasopressor dependency index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mortality-1

    28 days from inclusion into the study

  • Mortality-2

    From admission to the ICU until discharge or transfer from the ICU (up to one year)

  • Mortality-3

    From admission to discharge from the hospital (up to one year)

  • Inflammation

    Within 48h after the onset of CytoSorb treatment

  • Respiratory outcome

    Within 28 days after the onset of CytoSorb treatment

  • +1 more secondary outcomes

Study Arms (2)

CytoSorb

ACTIVE COMPARATOR

CytoSorb therapy for 48h

Device: CytoSorb

Matched controls

NO INTERVENTION

60 matched controls with SAP and transpulmonary thermodilution monitoring

Interventions

CytoSorbDEVICE

Two consecutive 24h treatments with the CytoSorb-device

CytoSorb

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proven acute pancreatitis:
  • typical pain
  • at least 3-fold increase in serum lipase
  • 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
  • +1 more criteria

You may not qualify if:

  • pregnancy
  • lack of informed consent of patient or representative
  • pre-existing disease with life expectancy \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huber W, Algul 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.

    PMID: 30681551DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Wolfgang Huber, Professor

    II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Huber, Professor

CONTACT

++49-89-4140-5214Wolfgang.Huber@tum.de

Tobias Lahmer, MD

CONTACT

++49-89-4140-9345Tobias.Lahmer@mri.tum.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Inflammatory cytokine removal by Cyto Sorb treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Wolfgang Huber

Study Record Dates

First Submitted

January 13, 2017

First Posted

March 17, 2017

Study Start

March 15, 2017

Primary Completion

February 1, 2018

Study Completion

July 1, 2018

Last Updated

March 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share