EUCTR2013-002390-21-NL
Active, not recruiting
Phase 1
Effects of oxygen status on endotoxemia induced inflammation and Hypoxia Inducible Factor 1-a. A pilot proof of principle study.
Radboud University Nijmegen Medical Centre0 sites30 target enrollmentAugust 20, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Possible future indications: inflammatory conditions in general, autoimmune diseases
- Sponsor
- Radboud University Nijmegen Medical Centre
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age\>18 and \<35 yrs
- •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 30
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\-Use of any medication
- •\-History, signs or symptoms of cardiovascular disease
- •\-History of atrial or ventricular arrhythmia
- •\-(Family) history of myocardial infarction or stroke under the age of 65 years
- •\-Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
- •\-Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90 mmHg)
- •\-Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50 mmHg)
- •\-Renal impairment (defined as plasma creatinine \>120 µmol/l)
- •\-Liver enzyme abnormalities alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
- •\-Medical history of any obvious disease associated with immune deficiency
Outcomes
Primary Outcomes
Not specified
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