Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052125
• Other study ID #: 2019-002498-80 substudy
• Status: Recruiting
• Phase: Phase 4
• Start date: December 16, 2021
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Hospital of South West Jutland
• Contact: Mikkel Brabrand, MD, Ph.D
• Phone: +4540736373
• Email: mikkel.brabrand[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.

Description:

Studies have shown that oxidative stress plays a critical role in the pathogenesis of COPD and its comorbidities. Oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ROS)) outweighs that of antioxidants. ROS can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of ATP production in mitochondria or from immune cells during oxidative burst. When high fractions of inspired oxygen are administered, excess O2 can lead to formation of additional ROS, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. In turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. During the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis. This substudy therefore aim to investigate the relation between oxygen therapy in COPD patients admitted with acute exacerbation, oxidative stress, and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or older
• ability to give informed consent
• previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
• admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
• requiring oxygen treatment

Exclusion Criteria:

• Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
• Expected total length of stay in hospital < 12 hours
• Planned transfer to another hospital within 12 hours
• Unwilling to have repeated arterial blood gas analyses within the first 12 hours
• Patients judged terminal by treating physician in the emergency department
• Non-residents of the particular country
• Expected impossible follow-up
• Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
• Prior participation in the study

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Oxygen
Administering oxygen to achieve the desired peripheral oxygen saturation

Locations

Country	Name	City	State
Denmark	Hospital of Southern Denmark, Esbjerg	Esbjerg
Denmark	Kolding Hospital, Sygehus Lillebælt	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Mikkel Brabrand	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress levels (systemic and lung 8-isopropane levels).		Immediately after study completion
Secondary	Inflammation levels (systemic and lung IL-8 levels)		Immediately after study completion
Secondary	7-day all-cause mortality and 30-day all-cause mortality	extracted from the Danish national registries	30 days
Secondary	over-all length of hospital stay	calculated from the hospital records	Immediately after study completion
Secondary	respiratory acidosis	measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia	Immediately after the procedure