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

Phase 4

Recruiting

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
High oxygen saturation	Oxygen	Peripheral oxygen saturation level \>94% Intervention: Drug: Oxygen gas
Low oxygen saturation	Oxygen	Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas

Primary Outcome Measures

Name	Time	Method
Oxidative stress levels (systemic and lung 8-isopropane levels).	Immediately after study completion

Secondary Outcome Measures

Name	Time	Method
Inflammation levels (systemic and lung IL-8 levels)	Immediately after study completion
7-day all-cause mortality and 30-day all-cause mortality	30 days	extracted from the Danish national registries
over-all length of hospital stay	Immediately after study completion	calculated from the hospital records
respiratory acidosis	Immediately after the procedure	measured as an arterial blood gas analysis with pH \< 7.35 and hypercapnia

Locations (2): Hospital of Southern Denmark, Esbjerg
🇩🇰
Esbjerg, Denmark
Kolding Hospital, Sygehus Lillebælt
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Kolding, Denmark

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