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

NCT00559130 | Completed DMC

• 1 other identifier: 2007-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Lung Injury; Sepsis

Keywords

Acute Respiratory Distress Syndrome; Acute Lung Injury; Sepsis; Hemoperfusion

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  28 Days

Interventions

CytoSorb Hemoperfusion DEVICE

Daily hemoperfusion for 6 hours with CytoSorb device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedaSorb Technologies, Inc: lead

Study Sites (6)

Unknown Facility

Aachen, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Erfurt, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

Kiel, Germany

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury; Sepsis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin K Kuhlmann, Prof. Dr.

  Vivantes Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

DE (6)