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

NCT ID: NCT05052125

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High oxygen saturation

Peripheral oxygen saturation level \>94% Intervention: Drug: Oxygen gas

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

Administering oxygen to achieve the desired peripheral oxygen saturation

Low oxygen saturation

Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

Administering oxygen to achieve the desired peripheral oxygen saturation

Interventions

Oxygen

Administering oxygen to achieve the desired peripheral oxygen saturation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Mikkel Brabrand

OTHER

Sponsor Role: lead

Responsible Party

Mikkel Brabrand

Professor, ph.d., MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital of Southern Denmark, Esbjerg

Esbjerg, , Denmark

Kolding Hospital, Sygehus Lillebælt

Kolding, , Denmark

Countries

Denmark

Other Identifiers

2019-002498-80 substudy

Identifier Type: -

Identifier Source: org_study_id