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Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04612270
Enrollment
22
Registered
2020-11-02
Start date
2020-11-04
Completion date
2021-06-01
Last updated
2021-09-08

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

Conditions

Oxygen Deficiency

Brief 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.

Interventions

Two venous blood collections in within one week. No drug-related intervention in-vivo.

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
P50One dayPartial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.

Secondary

MeasureTime frameDescription
Hill coefficientOne dayParameter describing the cooperativity of oxygen ligand binding to haemoglobin.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026