Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

NCT ID: NCT04612270

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2021-06-01

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.

Conditions

Oxygen Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Participants for blood collection

The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.

Group Type: EXPERIMENTAL

Venous blood collection

Intervention Type: OTHER

Two venous blood collections in within one week. No drug-related intervention in-vivo.

Interventions

Venous blood collection

Two venous blood collections in within one week. No drug-related intervention in-vivo.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Ströhle, MD

Role: PRINCIPAL_INVESTIGATOR

MUI, Department of Anaesthesiology and Critical Care Medicine

Locations

Department of Anaesthesiology and Critical Care Medicine

Innsbruck, Tyrol, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 35948604 (View on PubMed)

Other Identifiers

1265/2020

Identifier Type: -

Identifier Source: org_study_id