EUCTR2007-007132-25-DE
Active, not recruiting
Not Applicable
A randomized, double blind, parallel, placebo controlled, exploratory study to assess the effect of EA-230 on renal function and on safety and tolerability in patients at increased risk of developing renal failure following major cardiac on-pump surgery.
EBI Anti Sepsis B.V.0 sites150 target enrollmentFebruary 11, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EBI Anti Sepsis B.V.
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female patients of at least 18 years old
- •2\.Patients who are scheduled to undergo major elective cardiac surgery
- •3\.Patients who are willing to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Patients undergoing emergency surgery.
- •2\.Severe congestive heart failure EF \< 20 %.
- •3\.Congenital heart disease other than corrected atrial septum defect or corrected ventricular septum defect.
- •4\.Patients with a known malignancy or a history of malignancy, other than successfully treated non\-metastatic basal or squamous cell carcinoma of the skin
- •5\.Previous organ transplantation.
- •6\.Active or uncontrolled liver disease/hepatitis.
- •7\.Any disease that (a) has required immunosuppressive drugs (including oral or parenteral corticosteroids) during the past 6 months, or that (b) is fairly likely to require administration of such drugs in the post\-operative period. Examples of such diseases include COPD, asthma, chronic bronchitis, auto\-immune diseases, and so on. However, inhaled or topical steroids are permitted.
- •8\.Patients who are unable themselves to sign the informed consent form, whether because of strokes or cognitive defects (dementia or otherwise).
- •9\.Confirmed HIV\-positivity.
- •10\.Active (acute) infectious disease and/or severe chronic infectious disease requiring antibiotic treatment.
Outcomes
Primary Outcomes
Not specified
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