Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Not Applicable

Completed

• Conditions: Oxygen Deficiency
• Interventions: Other: Venous blood collection

• Registration Number: NCT04612270
• Lead Sponsor: Medical University Innsbruck

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2020-11-04
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants for blood collection	Venous blood collection	The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.

Primary Outcome Measures

Name	Time	Method
P50	One day	Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.

Secondary Outcome Measures

Name	Time	Method
Hill coefficient	One day	Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.

Trial Locations

Locations (1)

Department of Anaesthesiology and Critical Care Medicine; 🇦🇹 Innsbruck, Tyrol, Austria