Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring oxygen, oxidative stress, mortality
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
Sites / Locations
- Hospital of Southern Denmark, EsbjergRecruiting
- Kolding Hospital, Sygehus LillebæltRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High oxygen saturation
Low oxygen saturation
Arm Description
Peripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas
Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas
Outcomes
Primary Outcome Measures
Oxidative stress levels (systemic and lung 8-isopropane levels).
Secondary Outcome Measures
Inflammation levels (systemic and lung IL-8 levels)
7-day all-cause mortality and 30-day all-cause mortality
extracted from the Danish national registries
over-all length of hospital stay
calculated from the hospital records
respiratory acidosis
measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia
Full Information
NCT ID
NCT05052125
First Posted
September 7, 2021
Last Updated
October 31, 2022
Sponsor
Mikkel Brabrand
Collaborators
Region of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05052125
Brief Title
Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)
Official Title
Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Brabrand
Collaborators
Region of Southern Denmark
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
oxygen, oxidative stress, mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High oxygen saturation
Arm Type
Active Comparator
Arm Description
Peripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas
Arm Title
Low oxygen saturation
Arm Type
Active Comparator
Arm Description
Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Administering oxygen to achieve the desired peripheral oxygen saturation
Primary Outcome Measure Information:
Title
Oxidative stress levels (systemic and lung 8-isopropane levels).
Time Frame
Immediately after study completion
Secondary Outcome Measure Information:
Title
Inflammation levels (systemic and lung IL-8 levels)
Time Frame
Immediately after study completion
Title
7-day all-cause mortality and 30-day all-cause mortality
Description
extracted from the Danish national registries
Time Frame
30 days
Title
over-all length of hospital stay
Description
calculated from the hospital records
Time Frame
Immediately after study completion
Title
respiratory acidosis
Description
measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia
Time Frame
Immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Brabrand, MD, Ph.D
Phone
+4540736373
Email
mikkel.brabrand@rsyd.dk
Facility Information:
Facility Name
Hospital of Southern Denmark, Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Brabrand
Phone
+4540736373
Email
mikkel.brabrand@rsyd.dk
Facility Name
Kolding Hospital, Sygehus Lillebælt
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Daugaard Thuesen, MD, Ph.D
Email
Anne.Daugaard.Thuesen2@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Simon Thorgaard-Rasmussen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)
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