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CompletedNCT04612270Updated Sep 8, 2021

Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

An interventional study of Venous blood collection in Oxygen Deficiency, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-08.

Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oxygen Deficiency

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 22 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Informed consent
  • ASA 1 (American Society of Anesthesiologists classification)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Participants for blood collection

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

    Other: Venous blood collection

Interventions

  • OtherVenous blood collection

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

06

What researchers measure

Primary outcomes

  1. P50

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

    Time frame: One day

Secondary outcomes

  1. Hill coefficient

    Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.

    Time frame: One day

07

Study locations

1 site
  • Department of Anaesthesiology and Critical Care Medicine
    Innsbruck, Tyrol 6122, Austria
08

References and documents

Publications

  • Ronzani M, Woyke S, Mair N, Gatterer H, Oberacher H, Plunser D, Haller T, Strohle M, Rugg C. The effect of desflurane, isoflurane and sevoflurane on the hemoglobin oxygen dissociation curve in human blood samples. Sci Rep. 2022 Aug 10;12(1):13633. doi: 10.1038/s41598-022-17789-6. PubMed 35948604 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04612270
Lead sponsor
Medical University Innsbruck
Responsible party
Sponsor
First posted
Nov 2, 2020
Start date
Nov 4, 2020
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Sep 8, 2021

Study contacts

Mathias Ströhle, MD
principal investigator · MUI, Department of Anaesthesiology and Critical Care Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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