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

• Sponsor: Mikkel Brabrand (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05052125
• Collaborator: Region of Southern Denmark (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 7.5
• Patients Per Site: 25
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Oxygen	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality
• Actual Study Start Date: Dec 16, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High oxygen saturation Peripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas	Drug: Oxygen; Administering oxygen to achieve the desired peripheral oxygen saturation
Active Comparator: Low oxygen saturation Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas	Drug: Oxygen; Administering oxygen to achieve the desired peripheral oxygen saturation

Outcome Measures

Primary Outcome Measures

1. Oxidative stress levels (systemic and lung 8-isopropane levels). [Immediately after study completion]

Secondary Outcome Measures

1. Inflammation levels (systemic and lung IL-8 levels) [Immediately after study completion]

2. 7-day all-cause mortality and 30-day all-cause mortality [30 days]

   extracted from the Danish national registries

3. over-all length of hospital stay [Immediately after study completion]

   calculated from the hospital records

4. respiratory acidosis [Immediately after the procedure]

   measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of Southern Denmark, Esbjerg	Esbjerg		Denmark	6700
2	Kolding Hospital, Sygehus Lillebælt	Kolding		Denmark	6000

Sponsors and Collaborators

• Mikkel Brabrand
• Region of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mikkel Brabrand, Professor, ph.d., MD, Sydvestjysk Hospital
• ClinicalTrials.gov Identifier: NCT05052125
• Other Study ID Numbers: 2019-002498-80 substudy
• First Posted: Sep 22, 2021
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Mikkel Brabrand, Professor, ph.d., MD, Sydvestjysk Hospital: oxygen; oxidative stress; mortality
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 18, 2022