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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03082469
Other study ID # PACIFIC 10-2015
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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