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Lack of inclusion of patients
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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
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As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High oxygen saturation | Active Comparator | Peripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas |
|
| Low oxygen saturation | Active Comparator | Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Administering oxygen to achieve the desired peripheral oxygen saturation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress levels (systemic and lung 8-isopropane levels). | Immediately after study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation levels (systemic and lung IL-8 levels) | Immediately after study completion | |
| 7-day all-cause mortality and 30-day all-cause mortality | extracted from the Danish national registries |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Southern Denmark, Esbjerg | Esbjerg | 6700 | Denmark | |||
| Kolding Hospital, Sygehus Lillebælt |
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| 30 days |
| over-all length of hospital stay | calculated from the hospital records | Immediately after study completion |
| respiratory acidosis | measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia | Immediately after the procedure |
| Kolding |
| 6000 |
| Denmark |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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