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.

Study Overview

• Status: Completed
• Conditions: Oxygen Deficiency
• Intervention / Treatment: Other: Venous blood collection

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Two venous blood collections in within one week. No drug-related intervention in-vivo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P50	Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hill coefficient	Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.	One day

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Mathias Ströhle, MD, MUI, Department of Anaesthesiology and Critical Care Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2020
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 1265/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No