Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Study Overview
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Brief Summary
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The presented study is an experimental in-vitro study without intervention in-vivo. The effects of nitric oxide and prostacyclins, 5-hydroxymethylfurfural and alpha-ketoglutarate, volatile anaesthetics on haemoglobin oxygen (HbO2) affinity will be investigated in-vitro. Venous blood samples of 20 healthy young volunteers (10 female, 10 male) will be collected twice in the period of one week. Informed consent will be given. Every blood collection will be accompanied by a venous blood gas analysis. The blood samples will be transferred to the laboratory for in-vitro recording of the complete oxygen dissociation curve (ODC). A newly developed in-vitro method will be used. On the first study day the blood samples will be exposed to three different concentrations of nitric oxide during the measurement, followed by two different vapourized prostacyclins. In addition, different concentrations of 5-hydroxymethylfurfural and alpha-ketoglutarate will be given to the blood samples for ODC recording. On the second study day the dose dependent effects of three different volatile anaesthetics will be investigated by exposing the blood samples to these drug while the measurements. Following these ODC recordings, aliquots of the blood samples will be frozen and investigated for storage related changes in HbO2 affinity.

Official Title
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Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Conditions
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Oxygen Deficiency

Intervention / Treatment
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* Other: Venous blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent ASA 1 (American Society of Anesthesiologists classification) Exclusion Criteria: Any drug intake within 10 days prior to blood collection Smoking Haemoglobinopathy Acute inflammatory disease within 14 days prior to blood collection Pregnancy or breastfeeding Severe trauma or blood loss within 14 days prior to blood collection Participation in any other clinical study High altitude sojourn for several days (> 3,000 m) within four weeks prior to blood collection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants for blood collection<br>The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo. | Other: Venous blood collection<br>* Two venous blood collections in within one week. No drug-related intervention in-vivo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P50 | Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hill coefficient | Parameter describing the cooperativity of oxygen ligand binding to haemoglobin. | One day |