In this study we will therefore investigate the influence of hypoxia and anti oxidants on HVR and HPV.
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
pulmonal arterial pressure
total oxidant capacity
The ventilation will be analyzed on-line and is visible on-screen using custom
made software (ACQ and RESREG developed by Erik Olofsen and Erik Kruyt,
respectively). The breathing data will be collected on disc on a
breath-to-breath basis for further analysis.zie protocol pagina 6 data steering
Secondary outcome
none
Background summary
The background mechanism of the oxygen sensing in the human body still remains
to be elucidated. One of the proposed mechanisms is through the mitochondrial
reactive oxygen species hypothesis. This hypothesis states that tissue hypoxia
generates ROS. These ROS then would influence the ventilatory respons through
the carotid bodies and the reactivity of the pulmonary arterial smooth muscle
cells.
Study objective
In this study we will therefore investigate the influence of hypoxia and anti
oxidants on HVR and HPV.
Study design
double blind placebo controlled trial
three following sessions:
1. placebo
2. ascobid acid
3. acetylcystein
Intervention
arterial line,
venous line
hyperoxia
hypoxia
Study burden and risks
The strain for the volunteers considering the study medications is nausea and
vomiting when taken in high dosages. The dosages durng this investigation will
be much lower.
Hypoxia might cause a headache, which will be treated with paracetamol.
The venous and arterial lines might cause a haematoma, which will disappear by
itself. Arterial lines are related with clothing, but only when more than 36
hours in situ. During this investigation the arterial line will be no longer in
situ than 4 hours.
albinusdreef 2
2333 ZC Leiden
NL
albinusdreef 2
2333 ZC Leiden
NL
Listed location countries
Age
Inclusion criteria
That the volunteer is healthy
Exclusion criteria
Exclusion criteria are:
• Obesity (BMI > 30)
• Presence of medical disease: heart-, lung-, liver-, kidney- and lung disease; diabetes
• Presence of psychiatric disease
• History of chronic alcohol or drug use
• Possibility of pregnancy
• Lactation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-008453-29-NL |
| CCMO | NL26258.058.09 |