Oxygen DeficiencyNCT04612270
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
A study testing Venous blood collection in people with Oxygen Deficiency, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- Venous blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 4 Nov 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- ASA 1 (American Society of Anesthesiologists classification)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Department of Anaesthesiology and Critical Care Medicine
Innsbruck, Tyrol, 6122
About this study
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.
- Conditions
- Oxygen Deficiency
- Being tested
- Venous blood collection
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood collectionOther
Two venous blood collections in within one week. No drug-related intervention in-vivo.
| Study group | Role | What they receive |
|---|---|---|
| Participants for blood collection | Experimental | The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo. Receives: Other: Venous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
P50
Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.
Measured: One day
Secondary outcomes (1)
Hill coefficient
Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start4 Nov 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Ströhle, MD, Principal investigator, MUI, Department of Anaesthesiology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612270
- Sponsor's protocol ID
- 1265/2020
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
- ClinicalTrials.gov ID
- NCT04612270
- Acronym / sponsor ID
- 1265/2020
- Conditions
- Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants for blood collection | Experimental | Other: Venous blood collectionThe blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Informed consent
- ASA 1 (American Society of Anesthesiologists classification)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood collectionTwo venous blood collections in within one week. No drug-related intervention in-vivo. | Other | Participants for blood collection |
Primary outcome
P50
Time frame: One day
Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.
1 secondary outcome
Hill coefficient
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 35948604Ronzani 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.
- Individual participant dataSharing planned: No
Related trials for Oxygen Deficiency
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Sustained Cord Circulation at Emergency Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Ströhle, MD principal investigator
MUI, Department of Anaesthesiology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous blood collection in people with Oxygen Deficiency, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P50 (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.