ANZCTR - Registration

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:30pm (AEST) on Thursday 5th June for website maintenance.
Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Magnesium disorders

Chronic Obstructive Pulmonary Disease

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mortality

Timepoint [1]

The day on admission to critical care unit until discharge

Secondary outcome [1]

Invasive or non-invasive mechanic ventilation

Timepoint [1]

The day on admission to critical care unit until discharge

Secondary outcome [2]

Length of mechanical ventilation

Timepoint [2]

The day on admission to critical care unit until discharge

Secondary outcome [3]

Length of critical care unit stay

Timepoint [3]

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?

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]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Ceren Önal (Agri Training and Research Hospital)

Address

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Agri Ibrahim Çeçen University Ethics Committee

Ethics committee address [1]

+904722159863  hukukburosu@agri.edu.tr

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

11/02/2025

Approval date [1]

27/02/2025

Ethics approval number [1]

E-95531838-050.99-127597

Summary

Brief summary

This retrospective observational study focuses on COPD patients admitted to the critical care unit. Serum magnesium levels recorded on the date of admission were retrieved from the electronic database. The primary hypothesis is that dysmagnesemia is associated with increased mortality. Additionally, the study evaluates the relationship between magnesium levels and the need for mechanical ventilation, the duration of mechanical ventilation, and the length of hospital stay.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ceren Önal

Address

Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200

Country

Turkey

Phone

+905346869830

Fax

[email protected]

Contact person for public queries

Name

Ceren Önal

Address

Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200

Country

Turkey

Phone

+905346869830

Fax

[email protected]

Contact person for scientific queries

Name

Ceren Önal

Address

Agri Training and Research Hospital, Çevreyolu Suçatagi Mevkii, Agri, 04200

Country

Turkey

Phone

+905346869830

Fax

[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?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24624	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.

Trial Review

Documents added manually

Documents added automatically