Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000558426
Ethics application status
Approved
Date submitted
12/04/2025
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of serum magnesium levels on critically ill COPD patients: A retrospective study
Scientific title
The effect of serum magnesium levels on criitically ill patients with chronic obstructive pulmonary disease: A retrospective observational study
Secondary ID [1] 314177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Magnesium disorders 337031 0
Chronic Obstructive Pulmonary Disease 337032 0
Condition category
Condition code
Anaesthesiology 333482 333482 0 0
Other anaesthesiology
Respiratory 333483 333483 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The relationship between serum magnesium levels and clinical outcomes, including mortality and the need for invasive or non-invasive mechanical ventilation, has yet to be thoroughly investigated specifically in COPD patients admitted to the ICU.

This study aims to investigate the impact of serum magnesium levels on mortality and other clinical outcomes—such as mechanical ventilation requirements, ventilation duration, and ICU length of stay—in critically ill patients with COPD, contributing valuable insights into the management of this patient population. Relevant data, including patients’ gender, age, existing co-morbidities, serum magnesium levels on admission, mechanical ventilation status, mortality, and length of stay, will be collected from medical records, with no active participation required from the patients. The observation period will begin on the day of ICU admission and continue until the patient is discharged.
Intervention code [1] 330778 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341062 0
Mortality
Timepoint [1] 341062 0
The day on admission to critical care unit until discharge
Secondary outcome [1] 445999 0
Invasive or non-invasive mechanic ventilation
Timepoint [1] 445999 0
The day on admission to critical care unit until discharge
Secondary outcome [2] 446167 0
Length of mechanical ventilation
Timepoint [2] 446167 0
The day on admission to critical care unit until discharge
Secondary outcome [3] 446168 0
Length of critical care unit stay
Timepoint [3] 446168 0
The day on admission to critical care unit until discharge

Eligibility
Key inclusion criteria
The study includes COPD patients over 18 years admitted to critical care unit between January 2024 and January 2025
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who take magnesium supplements are excluded.

Study design
Purpose
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/02/2025
Date of last participant enrolment
Anticipated
Actual
11/04/2025
Date of last data collection
Anticipated
Actual
11/04/2025
Sample size
Target
200
Accrual to date
Final
265
Recruitment outside Australia
Country [1] 26963 0
Turkey
State/province [1] 26963 0

Funding & Sponsors
Funding source category [1] 318694 0
Self funded/Unfunded
Name [1] 318694 0
Country [1] 318694 0
Primary sponsor type
Individual
Name
Ceren Önal (Agri Training and Research Hospital)
Address
Country
Turkey
Secondary sponsor category [1] 321146 0
None
Name [1] 321146 0
Address [1] 321146 0
Country [1] 321146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317303 0
Agri Ibrahim Çeçen University Ethics Committee
Ethics committee address [1] 317303 0
Ethics committee country [1] 317303 0
Turkey
Date submitted for ethics approval [1] 317303 0
11/02/2025
Approval date [1] 317303 0
27/02/2025
Ethics approval number [1] 317303 0
E-95531838-050.99-127597

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140626 0
Dr Ceren Önal
Address 140626 0
Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200
Country 140626 0
Turkey
Phone 140626 0
+905346869830
Fax 140626 0
Email 140626 0
[email protected]
Contact person for public queries
Name 140627 0
Ceren Önal
Address 140627 0
Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200
Country 140627 0
Turkey
Phone 140627 0
+905346869830
Fax 140627 0
Email 140627 0
[email protected]
Contact person for scientific queries
Name 140628 0
Ceren Önal
Address 140628 0
Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200
Country 140628 0
Turkey
Phone 140628 0
+905346869830
Fax 140628 0
Email 140628 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Uzman Dr. Ceren ÖNAL Etik Kurul Karari.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.