Back to resultsQuantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
Primary Purpose
Oxygen Deficiency
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Venous blood collection
Sponsored by
About this trial
This is an interventional basic science trial for Oxygen Deficiency
Eligibility Criteria
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
Sites / Locations
- Department of Anaesthesiology and Critical Care Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants for blood collection
Arm Description
The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.
Outcomes
Primary Outcome Measures
P50
Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.
Secondary Outcome Measures
Hill coefficient
Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.
Full Information
NCT ID
NCT04612270
First Posted
October 27, 2020
Last Updated
September 7, 2021
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT04612270
Brief Title
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
Official Title
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Deficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants for blood collection
Arm Type
Experimental
Arm Description
The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.
Intervention Type
Other
Intervention Name(s)
Venous blood collection
Intervention Description
Two venous blood collections in within one week. No drug-related intervention in-vivo.
Primary Outcome Measure Information:
Title
P50
Description
Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Hill coefficient
Description
Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.
Time Frame
One day
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
10 female and 10 male participants.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Ströhle, MD
Organizational Affiliation
MUI, Department of Anaesthesiology and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesiology and Critical Care Medicine
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6122
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35948604
Citation
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.
Results Reference
derived
Learn more about this trial
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
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