Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytoki... | NCT03082469

Studies
Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal

NCT03082469

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Mar 17, 2017Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Pancreatitis, Acute
SIRS

Interventions

CytoSorb

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2017Estimated

Primary Completion Date

Feb 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jan 13, 2017

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2017

Last Update Posted Date

Mar 17, 2017Actual

Name	Class
CytoSorbents Europe GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CytoSorb	Active Comparator	CytoSorb therapy for 48h	Device: CytoSorb
Matched controls	No Intervention	60 matched controls with SAP and transpulmonary thermodilution monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CytoSorb	Device	Two consecutive 24h treatments with the CytoSorb-device	CytoSorb

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality-1	28-days-mortality	28 days from inclusion into the study
Mortality-2	ICU-mortality	From admission to the ICU until discharge or transfer from the ICU (up to one year)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wolfgang Huber, Professor	Contact	++49-89-4140-5214		Wolfgang.Huber@tum.de
Tobias Lahmer, MD	Contact	++49-89-4140-9345		Tobias.Lahmer@mri.tum.de

Overall Officials

Name	Affiliation	Role
Wolfgang Huber, Professor	II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30681551	Derived	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.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases