Effects of oxygen status on Hypoxia Inducible Factor 1-a. A pilot proof of principle study.

Completed

• Conditions: sepsis; infection in the blood; 10027665; 10002252

• Registration Number: NL-OMON38504
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Age >=18 and <=35
-Male
-Healthy

Exclusion Criteria

-Use of any medication, smoking
-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), hypotension (defined as RR systolic < 100 or RR diastolic < 50)
-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, pre-existent lung disease or asthma
-CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
-Participation in a drug trial or donation of blood 3 months prior to the experiment, use of recreational drugs within 21 days prior to experiment day, visit to altitude >1500m within 4 weeks prior to the experiment, air travel with flight time over 3 hours within 4 weeks prior to the experiment, history of acute mountain sickness, recent hospital admission or surgery with general anaesthesia (<3 months)
-Claustrophobia
-Feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in HIF1a mRNA in circulating<br /><br>leukocytes between hypoxia and hyperoxia. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are HIF1a protein and aHIF mRNA expression in circulating<br /><br>leukocytes, measures of ROS, and plasma levels of inflammatory cytokines. </p><br>