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Completed

NCT Number: NCT04612270

Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

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.

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Key information

Conditions

Oxygen Deficiency Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Critical Care Medicine

Innsbruck, Tyrol, 6122, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous blood collection

Other

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

Primary outcomes

  1. P50

    Time frame: One day

    Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.

Secondary outcomes

  1. Hill coefficient

    Time frame: One day

    Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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