Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-01 @ 9:06 AM
Study NCT ID:
NCT07089004
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypomagnesemia and Its Clinical Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of Hypomagnesemia with ICU Mortality', 'timeFrame': 'From the date of ICU admission until the date of ICU discharge or death, assessed up to 60 days.', 'description': 'To assess the relationship between low serum magnesium levels and all-cause mortality among critically ill ICU patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypomagnesemia', 'Critical Illness', 'Intensive Care Unit (ICU) Patients', 'Scoring Systems']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and above.\n* Patients admitted to the Intensive Care Unit (ICU).\n* Patients who have serum magnesium levels measured within 24 hours of ICU admission.\n\nExclusion Criteria:\n\n* Patients with known end-stage renal disease on dialysis.\n* Patients with a history of magnesium supplementation prior to ICU admission.\n* Pregnant women.\n* Patients with incomplete medical records or unavailable laboratory data.'}, 'identificationModule': {'nctId': 'NCT07089004', 'acronym': 'Hypogamnesamia', 'briefTitle': 'Hypomagnesemia and Its Clinical Outcome', 'organization': {'class': 'NETWORK', 'fullName': 'Bangladesh Bioscience Research Group'}, 'officialTitle': 'Co-relation of Hypomagnesemia With Clinical Outcomes in Critically Ill Patients Admitted to a Tertiary Care ICU in Bangladesh', 'orgStudyIdInfo': {'id': 'BBMH/2023/RP-2342'}, 'secondaryIdInfos': [{'id': 'BBMH/June/2023/011', 'type': 'REGISTRY', 'domain': 'Institute of Applied Health Sciences-USTC (ex-Bangabandu Memorial Hospital)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention (observational study)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational - Biochemical, Hematological and Clinical Scoring Assessments'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4202', 'city': 'Chittagong', 'state': 'Khulshi', 'country': 'Bangladesh', 'facility': 'University of Science and Technology Chittagong (USTC)', 'geoPoint': {'lat': 22.3384, 'lon': 91.83168}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Bioscience Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Chattogram International Dental College', 'class': 'OTHER'}, {'name': 'Chittagong Medical College and Hospital', 'class': 'OTHER'}, {'name': 'Bangladesh Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lab-Incharge (Biochemist)', 'investigatorFullName': 'Pair Ahmed Jiko', 'investigatorAffiliation': 'Bangladesh Medical Research Council (BMRC)'}}}}