Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal

SIRS Clinical Trial

— PACIFIC  

Official title:

Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03082469
• Other study ID #: PACIFIC 10-2015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 13, 2017
• Last updated: March 10, 2017
• Start date: March 15, 2017
• Est. completion date: July 2018

Study information

• Verified date: March 2017
• Source: Technische Universität München
• Contact: Wolfgang Huber, Professor
• Phone: ++49-89-4140-5214
• Email: Wolfgang.Huber[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute
• SIRS

Intervention

Device:
• CytoSorb
Two consecutive 24h treatments with the CytoSorb-device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	CytoSorbents Europe GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality-1	28-days-mortality	28 days from inclusion into the study
Secondary	Mortality-2	ICU-mortality	From admission to the ICU until discharge or transfer from the ICU (up to one year)
Secondary	Mortality-3	Hospital-mortality	From admission to discharge from the hospital (up to one year)
Secondary	Inflammation	IL-6, CRP and PCT-values levels compared to before CytoSorb treatment	Within 48h after the onset of CytoSorb treatment
Secondary	Respiratory outcome	Ventilator-free days	Within 28 days after the onset of CytoSorb treatment
Secondary	Renal function and its Change over time	Daily classification according to KDIGO; comparison vs. before Cyto Sorb treatment	Within 28 days after the onset of CytoSorb treatment