Acute Respiratory Distress SyndromeNCT00559130
Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis
A study testing CytoSorb Hemoperfusion in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by MedaSorb Technologies, Inc at 6 sites in Germany.
Trial summary
The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in improved clearance of cytokines when compared to control patients receiving only the standard of care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis
- What is being tested?
- CytoSorb Hemoperfusion
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 6 sitesGermany
- Study dates
- Nov 2007to Jun 2011
- Phase
- Interventional
- 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
- Signed informed consent document (ICD)
- Male or female ≥ 18 and ≤ 80 years of age.
- Subjects must have diagnosis of ARDS or ALI, based on ARDSNet Definition, established within last 72 hours, confirmed by clinical, radiological, or physiologic findings
- Subject must be intubated
- ≤ 3 days on a ventilator prior to enrollment
- Subjects must have confirmed diagnosis of sepsis
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- Subject must have had at least 24 hours of antibiotic therapy
- Pre-menopausal female subjects must have negative pregnancy test.
- Subject must be available for periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study. Subject must have permanent home address to allow completion of 60 day follow-up.
- Subject or health care proxy has the ability to understand and willingness to sign the informed consent form.
Who cannot join
- Currently participating in another clinical study involving investigational chemical compound, biologic, or device within the last 30 days prior to the start of this trial.
- Neuromuscular disease that impairs the ability to ventilate spontaneously, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome and myasthenia gravis.
- Increased intracranial pressure, tricyclic antidepressant overdose, hemoglobin SS, hemoglobin SC or other conditions where hypercapnia would be contraindicated.
- Severe chronic respiratory disease including hospitalization within last 6 months for respiratory failure.
- Morbid obesity (Body Mass Index ≥40 kg/m2).
- Burns > 30% BSA, bone marrow transplant, lung transplant or end stage hepatic liver failure.
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- Subject with mean arterial pressure ≤ 60 mmHg regardless of use of pressor agents.
- Subject with active malignancy receiving chemotherapy or radiation treatment within last 60 days.
- Subjects with AIDS, CD4 count of < 200 or 14%, or the presence of an AIDS defining illness (HIV+ subjects may be enrolled)
- Subject with acute coronary syndrome.
- Subjects with decompensated heart failure with New York Heart Association (NYHA) classification IV
- Subjects with Chronic Kidney Disease (CKD) stage 5 will be excluded
- Subjects with end stage hepatic liver failure
- Subjects on immunosuppressive agents, excluding corticosteroids
- Platelets ≤ 20,000/mm3
- Subjects on anti-TNF therapy
- Subjects about to receive or receiving drotrecogin alpha (Xigris) therapy
- Subject is pregnant or breastfeeding.
- Subject has a known allergy to any component of the CytoSorb hemoperfusion device
- Subject has any active disease condition that could limit compliance with the study procedure, including but not limited to the following: acute coronary syndrome, life-threatening cardiac arrhythmia, or psychiatric or social conditions, considered by investigator(s) to preclude successful completion of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Study site
Aachen
Study site
Berlin
Study site
Bonn
Study site
Erfurt
Study site
Göttingen
Study site
Kiel
About this study
Official title: Multi-Center, Efficacy Study of the MedaSorb CytoSorb™ Hemoperfusion Device as an Adjunctive Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI) in the Setting of Sepsis
The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in improved clearance of cytokines when compared to control patients receiving only the standard of care.
Read the detailed description
Mortality rates from acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) range from 38.5 to 65%, with the lower mortality in acute lung injury than in ARDS.
ARDS/ALI is most often seen as part of a systemic inflammatory response syndrome (SIRS), particularly systemic sepsis. The lung findings parallel the damage in other tissues, namely, widespread destruction of the capillary endothelium, extravasation of protein rich fluid and interstitial edema. The alveolar basement membrane becomes damaged and fluid leaks into the airspaces, reducing lung compliance and causing ventilation-perfusion mismatch.
The most important causes of ALI/ARDS are sepsis, pneumonia, major trauma, pulmonary aspiration, near drowning, burns, inhalation of toxic gases (e.g. ammonia), fat embolism, amniotic fluid embolism, eclampsia, drug intoxication (e.g. aspirin), radiation injury and mechanical ventilation. Cox and colleagues have demonstrated in an ovine model of ARDS that there is intense acute inflammation in the trachea and bronchi from 3 to 48h after injury, with accumulation of neutrophils, fibrin and other plasma proteins, and mucus in airway lumens. Immunostaining for multiple cytokines (interleukin-8 (IL-8), IL-1beta, IL-1alpha, tumor necrosis factor-alpha (TNF-alpha), and vascular endothelial growth factor (VEGF)) are found in airway mucous glands, and the release of cytokines into the airway lumen are considered potentially highly significant in the progression of injury.
The importance of cytokines is being increasingly realized in mechanical lung injury (a common cause of ALI/ARDS) associated with mechanical ventilation (MV). Here the pathway is identical with release of cytokines/chemokines which potentiate the extravasation, activation, and recruitment of leukocytes, causing ventilator-associated lung injury (VALI) and ventilator-induced lung injury (VILI). Moreover, VALI/VILI can perpetuate the chronic inflammatory response during ALI/ARDS and multiple organ dysfunction syndrome (MODS).
The purpose of this study is to evaluate the reduction of cytokines, using the CytoSorb device, on primary and secondary endpoints
- Being tested
- CytoSorb Hemoperfusion
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis, Hemoperfusion
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb HemoperfusionDevice
Daily hemoperfusion for 6 hours with CytoSorb device
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative IL-6 levels as a percent (%) of baseline will be lower in subjects receiving CytoSorb treatment in conjunction with the standard of care as compared to control subjects receiving only the standard of care for ARDS/ALI in the setting of sepsis.
Measured: 7 Days
Secondary outcomes (1)
Ventilator Free Days, Reduction cytokines TNF-α, IL-1b, IL-10, CRP, 28-day all cause mortality, Oxygen Index (OI), P/F ratios, MODS scores
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedaSorb Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin K Kuhlmann, Prof. Dr., Principal investigator, Vivantes Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559130
- Sponsor's protocol ID
- 2007-01
- Status last verified
- Jun 2011
- First submitted
- 14 Nov 2007
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Efficacy Study of the MedaSorb CytoSorb™ Hemoperfusion Device as an Adjunctive Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI) in the Setting of Sepsis
- ClinicalTrials.gov ID
- NCT00559130
- Acronym / sponsor ID
- 2007-01
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis, Hemoperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MedaSorb Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Nov 2007 (estimated)
- 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.
The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in improved clearance of cytokines when compared to control patients receiving only the standard of care.
Detailed description
Mortality rates from acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) range from 38.5 to 65%, with the lower mortality in acute lung injury than in ARDS.
ARDS/ALI is most often seen as part of a systemic inflammatory response syndrome (SIRS), particularly systemic sepsis. The lung findings parallel the damage in other tissues, namely, widespread destruction of the capillary endothelium, extravasation of protein rich fluid and interstitial edema. The alveolar basement membrane becomes damaged and fluid leaks into the airspaces, reducing lung compliance and causing ventilation-perfusion mismatch.
The most important causes of ALI/ARDS are sepsis, pneumonia, major trauma, pulmonary aspiration, near drowning, burns, inhalation of toxic gases (e.g. ammonia), fat embolism, amniotic fluid embolism, eclampsia, drug intoxication (e.g. aspirin), radiation injury and mechanical ventilation. Cox and colleagues have demonstrated in an ovine model of ARDS that there is intense acute inflammation in the trachea and bronchi from 3 to 48h after injury, with accumulation of neutrophils, fibrin and other plasma proteins, and mucus in airway lumens. Immunostaining for multiple cytokines (interleukin-8 (IL-8), IL-1beta, IL-1alpha, tumor necrosis factor-alpha (TNF-alpha), and vascular endothelial growth factor (VEGF)) are found in airway mucous glands, and the release of cytokines into the airway lumen are considered potentially highly significant in the progression of injury.
The importance of cytokines is being increasingly realized in mechanical lung injury (a common cause of ALI/ARDS) associated with mechanical ventilation (MV). Here the pathway is identical with release of cytokines/chemokines which potentiate the extravasation, activation, and recruitment of leukocytes, causing ventilator-associated lung injury (VALI) and ventilator-induced lung injury (VILI). Moreover, VALI/VILI can perpetuate the chronic inflammatory response during ALI/ARDS and multiple organ dysfunction syndrome (MODS).
The purpose of this study is to evaluate the reduction of cytokines, using the CytoSorb device, on primary and secondary endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent document (ICD)
- Male or female ≥ 18 and ≤ 80 years of age.
- Subjects must have diagnosis of ARDS or ALI, based on ARDSNet Definition, established within last 72 hours, confirmed by clinical, radiological, or physiologic findings
- Subject must be intubated
- ≤ 3 days on a ventilator prior to enrollment
Key exclusion criteria (20 listed)
- Currently participating in another clinical study involving investigational chemical compound, biologic, or device within the last 30 days prior to the start of this trial.
- Neuromuscular disease that impairs the ability to ventilate spontaneously, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome and myasthenia gravis.
- Increased intracranial pressure, tricyclic antidepressant overdose, hemoglobin SS, hemoglobin SC or other conditions where hypercapnia would be contraindicated.
- Severe chronic respiratory disease including hospitalization within last 6 months for respiratory failure.
- Morbid obesity (Body Mass Index ≥40 kg/m2).
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 |
|---|---|---|
| CytoSorb HemoperfusionDaily hemoperfusion for 6 hours with CytoSorb device | Device | – |
Primary outcome
Relative IL-6 levels as a percent (%) of baseline will be lower in subjects receiving CytoSorb treatment in conjunction with the standard of care as compared to control subjects receiving only the standard of care for ARDS/ALI in the setting of sepsis.
Time frame: 7 Days
1 secondary outcome
Ventilator Free Days, Reduction cytokines TNF-α, IL-1b, IL-10, CRP, 28-day all cause mortality, Oxygen Index (OI), P/F ratios, MODS scores
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
Martin K Kuhlmann, Prof. Dr. principal investigator
Vivantes Klinikum
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb Hemoperfusion in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by MedaSorb Technologies, Inc at 6 sites in Germany.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative IL-6 levels as a percent (%) of baseline will be lower in subjects receiving CytoSorb treatment in conjunction with the standard of care as compared to control subjects receiving only the standard of care for ARDS/ALI in the setting of sepsis. (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2011.