Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal (PACIFIC)

Technical University of Munich

Status and phase: Unknown; Phase 4

Conditions: SIRS; Pancreatitis, Acute

Treatments: Device: CytoSorb

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03082469

PACIFIC 10-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

CytoSorb

Active Comparator group

Description:

CytoSorb therapy for 48h

Treatment:

Device: CytoSorb

Matched controls

No Intervention group

Description:

60 matched controls with SAP and transpulmonary thermodilution monitoring