Pancreatitis, AcutePhase 4PACIFICNCT03082469
Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal
A Phase 4 study testing CytoSorb in people with Pancreatitis, Acute and SIRS, run by Technical University of Munich.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis, Acute, SIRS
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2017to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- pregnancy
- lack of informed consent of patient or representative
- pre-existing disease with life expectancy <3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.
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.
Read the detailed 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.
- Conditions
- Pancreatitis, Acute, SIRS
- Being tested
- CytoSorb
- Keywords
- Severe acute pancreatitis, Haemodynamic monitoring, Cytokine removal, Vasopressor dependency index
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Two consecutive 24h treatments with the CytoSorb-device
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb | Active comparator | CytoSorb therapy for 48h Receives: Device: CytoSorb |
| Matched controls | No intervention | 60 matched controls with SAP and transpulmonary thermodilution monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamics
Improvement of the vasopressor dependency index >=20%. (Improvement of cardiac power index >=20% in case of no vasopressor use at baseline)
Measured: Within 48h after the onset of CytoSorb treatment
Secondary outcomes (6)
Mortality-1
28-days-mortality
Measured: 28 days from inclusion into the study
Mortality-2
ICU-mortality
Measured: From admission to the ICU until discharge or transfer from the ICU (up to one year)
Mortality-3
Hospital-mortality
Measured: From admission to discharge from the hospital (up to one year)
Inflammation
IL-6, CRP and PCT-values levels compared to before CytoSorb treatment
Measured: Within 48h after the onset of CytoSorb treatment
Respiratory outcome
Ventilator-free days
Measured: Within 28 days after the onset of CytoSorb treatment
Renal function and its Change over time
Daily classification according to KDIGO; comparison vs. before Cyto Sorb treatment
Measured: Within 28 days after the onset of CytoSorb treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start15 Mar 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Inflammatory cytokine removal by Cyto Sorb treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Responsible party
- Principal investigator, Wolfgang Huber, Technical University of Munich
- Investigators
- Wolfgang Huber, Professor, Principal investigator, II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082469
- Sponsor's protocol ID
- PACIFIC 10-2015
- Acronym
- PACIFIC
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30681551
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.
- ClinicalTrials.gov ID
- NCT03082469
- Acronym / sponsor ID
- PACIFIC / PACIFIC 10-2015
- Conditions
- Pancreatitis, Acute, SIRS
- Keywords
- Severe acute pancreatitis, Haemodynamic monitoring, Cytokine removal, Vasopressor dependency index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Study start
- 15 Mar 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Inflammatory cytokine removal by Cyto Sorb treatment
| Arm | Type | Receives |
|---|---|---|
| CytoSorb | Active comparator | Device: CytoSorbCytoSorb therapy for 48h |
| Matched controls | No intervention | –60 matched controls with SAP and transpulmonary thermodilution monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Proven acute pancreatitis:
- APACHE-II ≥10 AND
- ≥1 criterion of "severe sepsis" AND
- Haemodynamic monitoring with transpulmonary thermodilution AND
- ≥ 1 marker of poor prognosis of acute pancreatitis:
Key exclusion criteria (3 listed)
- pregnancy
- lack of informed consent of patient or representative
- pre-existing disease with life expectancy <3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbTwo consecutive 24h treatments with the CytoSorb-device | Device | CytoSorb |
Primary outcome
Haemodynamics
Time frame: Within 48h after the onset of CytoSorb treatment
Improvement of the vasopressor dependency index >=20%. (Improvement of cardiac power index >=20% in case of no vasopressor use at baseline)
6 secondary outcomes
Mortality-1
Time frame: 28 days from inclusion into the study
Mortality-2
Time frame: From admission to the ICU until discharge or transfer from the ICU (up to one year)
Mortality-3
Time frame: From admission to discharge from the hospital (up to one year)
Inflammation
Time frame: Within 48h after the onset of CytoSorb treatment
Respiratory outcome
Time frame: Within 28 days after the onset of CytoSorb treatment
Renal function and its Change over time
Time frame: Within 28 days after the onset of CytoSorb treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 30681551Huber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Huber, Professor principal investigator
II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CytoSorb in people with Pancreatitis, Acute and SIRS, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Huber, Professor (++49-89-4140-5214, Wolfgang.Huber@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamics (time frame: Within 48h after the onset of CytoSorb treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.