Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Sponsor

Medical University Innsbruck (Other)

Overall Status

Completed

CT.gov ID

NCT04612270

Collaborator

(none)

Enrollment

Location

Arm

6.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oxygen Deficiency	Other: Venous blood collection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

Actual Study Start Date :

Nov 4, 2020

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

P50 [One day]
Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.

Secondary Outcome Measures

Hill coefficient [One day]
Parameter describing the cooperativity of oxygen ligand binding to haemoglobin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Critical Care Medicine	Innsbruck	Tyrol	Austria	6122

Sponsors and Collaborators

Medical University Innsbruck

Investigators

Principal Investigator: Mathias Ströhle, MD, MUI, Department of Anaesthesiology and Critical Care Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University Innsbruck

ClinicalTrials.gov Identifier:

NCT04612270

Other Study ID Numbers:

1265/2020

First Posted:

Nov 2, 2020

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Sep 8, 2021