Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Medical University Innsbruck

Status: Completed

Conditions: Oxygen Deficiency

Treatments: Other: Venous blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04612270

1265/2020

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Participants for blood collection

Experimental group

Description:

The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.

Treatment:

Other: Venous blood collection