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ARA290 and the ventilatory response to hypoxia and pain responses in healthy volunteers.

ARA290 and the ventilatory response to hypoxia and pain responses in healthy volunteers.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23515
Enrollment
16
Registered
2011-11-01
Start date
2011-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Interventions

Healthy volunteers will each be seen for three sessions, with 2 weeks in between. Hypoxia will be induced using the computer driven Dynamic End-Tidal Forcing (DEF) Technique
end-tidal oxygen concentrations will be lowered to 5.8 kPa (about 45 mmHg) to reach an oxygen saturation of 80 ± 2 %, whereas the PCO2 level remains constant (end-tidal concentration is rest endtidal
P max) will be measured using Doppler echocardiography. An arterial line will provide information about the arterial blood gas and BP. Each time one substance, either NaCl 0,9%, Erythropoietin or ARA2

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The major inclusion criteria is that the subject has echo evidence of tricuspid regurgitation during systole, which is not clinically relevant but in fact can be demonstrated in most normal individuals.

Exclusion criteria

Exclusion criteria: 1. Obesity (BMI > 35); 2. Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia); 3. Presence of psychiatric disease; 4. History of chronic alcohol or illicit drug use; 5. Allergy to study medications. For females we require the use of oral contraceptives.

Design outcomes

Primary

MeasureTime frame
1. Hypoxic Ventilatory Response (HVR); 2. Pulmonary Artery Pressure (PAP).

Secondary

MeasureTime frame
1. Systolic and diastolic cardiac functions; 2. Vital and ventilatory parameters; 3. Pain thresholds under hypoxia.

Contacts

Public ContactR.R. Berendsen

Dept. of Anesthesiology LUMC, P5-Q

r.r.berendsen@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)