NCT07089004

Brief Summary

Magnesium is an essential electrolyte involved in numerous physiological processes, including maintaining cellular integrity, regulating muscle tone, supporting cardiovascular function, and modulating immune responses. Despite its critical role, magnesium is often overlooked in clinical practice, earning it the title of the "forgotten electrolyte." Hypomagnesemia, defined as serum magnesium levels below 1.5 mEq/L, has been associated with adverse clinical outcomes such as increased mortality, prolonged ICU stays, and higher requirements for mechanical ventilation. Critically ill patients are particularly vulnerable to hypomagnesemia due to various underlying conditions, gastrointestinal losses, and renal complications. However, limited data are available from Bangladesh on the burden and clinical impact of hypomagnesemia in ICU settings. This study aims to assess the correlation between hypomagnesemia and clinical outcomes, including length of ICU stay, need for mechanical ventilation, and mortality among critically ill patients in a tertiary care ICU in Bangladesh.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

June 29, 2025

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association of Hypomagnesemia with ICU Mortality

    To assess the relationship between low serum magnesium levels and all-cause mortality among critically ill ICU patients.

    From the date of ICU admission until the date of ICU discharge or death, assessed up to 60 days.

Interventions

Observational - Biochemical, Hematological and Clinical Scoring Assessments

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will consist of critically ill adult patients admitted to the Intensive Care Unit (ICU) of a tertiary care hospital in Bangladesh. The study will include both male and female patients aged 18 years and above, irrespective of their underlying diagnosis, provided they meet the inclusion criteria. Patients will be assessed for serum magnesium levels (Hypo; Normo and Hyper) within 24 hours of ICU admission, along with relevant biochemical, hematological and clinical parameters. The study will exclude individuals with known end-stage renal disease on dialysis, those receiving magnesium supplementation prior to ICU admission, pregnant women and patients with incomplete medical records.

You may qualify if:

  • Patients aged 18 years and above.
  • Patients admitted to the Intensive Care Unit (ICU).
  • Patients who have serum magnesium levels measured within 24 hours of ICU admission.

You may not qualify if:

  • Patients with known end-stage renal disease on dialysis.
  • Patients with a history of magnesium supplementation prior to ICU admission.
  • Pregnant women.
  • Patients with incomplete medical records or unavailable laboratory data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Science and Technology Chittagong (USTC)

Chittagong, Khulshi, 4202, Bangladesh

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood: Serum/Plasma Samples were collected from critically ill patients admitted to the Intensive Care Unit (ICU). The retained biospecimen will include serum samples, which will be used to measure serum magnesium levels and other relevant biochemical parameters as part of routine clinical assessment and research analysis.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lab-Incharge (Biochemist)

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 28, 2025

Study Start

June 1, 2024

Primary Completion

December 31, 2024

Study Completion

April 25, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared with other researchers to ensure the protection of patient confidentiality and comply with institutional and ethical guidelines. Only aggregated, de-identified data may be shared upon reasonable request and with appropriate ethical approvals.

Locations