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Clinical Trials/EUCTR2013-002390-21-NL
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.

Registry
who.int
Start Date
August 20, 2013
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Radboud University Nijmegen Medical Centre

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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