Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Oxygen Deficiency Clinical Trial

Official title:

Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612270
• Other study ID #: 1265/2020
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Other:
• Venous blood collection
Two venous blood collections in within one week. No drug-related intervention in-vivo.

Locations

Country	Name	City	State
Austria	Department of Anaesthesiology and Critical Care Medicine	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P50	Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.	One day
Secondary	Hill coefficient	Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.	One day