search
Back to results

Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CytoSorb Hemoperfusion
Sponsored by
MedaSorb Technologies, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis, Hemoperfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2007
Last Updated
June 6, 2011
Sponsor
MedaSorb Technologies, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00559130
Brief Title
Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedaSorb Technologies, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis
Keywords
Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis, Hemoperfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CytoSorb Hemoperfusion
Intervention Description
Daily hemoperfusion for 6 hours with CytoSorb device
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin K Kuhlmann, Prof. Dr.
Organizational Affiliation
Vivantes Klinikum
Official's Role
Principal Investigator
Facility Information:
City
Aachen
Country
Germany
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Erfurt
Country
Germany
City
Göttingen
Country
Germany
City
Kiel
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis

We'll reach out to this number within 24 hrs