CTRI

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CTRI Number

CTRI/2025/07/090783 [Registered on: 11/07/2025] Trial Registered Prospectively

Last Modified On:

11/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Detection of Hypomagnesemia in patients who have been diagnosed with sepsis on icu admission

Scientific Title of Study

Hypomagnesemia in Critically ill Sepsis Patients in ICU: A Hospital Based Cross- sectional study

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Arpit Agarwal
Designation	Postgraduate resident
Affiliation	School of medical science and research, sharda hospital, sharda university
Address	Department of anaesthesia and critical care School of medical science and research sharda hospital sharda university Knowledge park III greater Noida gautam buddh nagar uttar pradesh Gautam Buddha Nagar UTTAR PRADESH 201306 India
Phone	8860505875
Fax
Email	arpitaggarwal020@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ram Murti Sharma
Designation	Professor
Affiliation	School of medical science and research, sharda hospital, sharda university
Address	Department of anaesthesia and critical care School of medical science and research sharda hospital sharda university Knowledge park III greater Noida gautam buddh nagaruttar pradesh Gautam Buddha Nagar UTTAR PRADESH 201306 India
Phone	7798881243
Fax
Email	ram.sharma1@sharda.ac.in

Details of Contact Person
Public Query

Name	Dr Abhinandan Borah
Designation	Assistant professor
Affiliation	School of medical science and research, sharda hospital, sharda university
Address	Department of anaesthesia and critical care School of medical science and research sharda hospital sharda university Knowledge park III greater Noida gauram buddh nagar uttar pradesh Gautam Buddha Nagar UTTAR PRADESH 201306 India
Phone	8527189209
Fax
Email	abhinandan2@gmail.com

Source of Monetary or Material Support

Department of anaesthesia and critical care school of medical sciences and research, sharda hospital, sharda university knowledge park III gautam buddh nagar greater Noida pincode 201306

Primary Sponsor

Name	Department of anaesthesia and critical care school of medical sciences and research
Address	knowledge park 3, greater noida, gautam buddh nagar, Uttar Pradesh
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ram murti sharma	ICU sharda hospital	Sharda hospital Knowledge park III greater Noida uttar pradesh Gautam Buddha Nagar UTTAR PRADESH	7798881243 ram.sharma1@sharda.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E612\|\|Magnesium deficiency,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1.Patients diagnosed with sepsis (as per Sepsis-3 criteria) sofa score morethan 2admitted to the ICU. 2.Age 18 years and above irrespective of gender.

ExclusionCriteria

Details

1.Patient’s attendant refusing consent.
2.Patients below 18 years of age.
3.Patients with documented hypomagnesemia before admission, previous magnesium supplementation were excluded.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To estimate the prevalence of hypomagnesemia in critically ill patients admitted to multidisciplinary ICU	1 year 6 months

Secondary Outcome

Outcome	TimePoints
1.To identify underlying causes of hypomagnesemia in critically ill sepsis patient admitted to ICU. 2. To co-relate the association of hypomagnesemia with hypokalaemia. 3. To study outcomes especially mortality/morbidity in patients with hypomagnesemia.	1 year 6 months

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [arpitggarwal020@gmail.com].

For how long will this data be available start date provided 01-07-2025 and end date provided 30-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil

Brief Summary

This is a hospital-based cross-sectional observational study designed to evaluate the prevalence and clinical impact of hypomagnesemia in critically ill sepsis patients admitted to the intensive care unit ICU at Sharda Hospital Greater Noida. The study will be conducted from June 2025 to December 2026 and will include 100 adult patients diagnosed with sepsis based on Sepsis 3 criteria and admitted to the multidisciplinary ICU. Patients under 18 years of age those with prior documented hypomagnesemia or those receiving magnesium supplementation before admission will be excluded.

Serum magnesium levels will be measured within 24 hours of sepsis diagnosis and monitored every 48 to 72 hours during the ICU stay. Hypomagnesemia will be defined as serum magnesium less than 1.6 milligrams per deciliter. Additional parameters such as serum potassium levels SOFA score ventilator requirements duration of ICU stay and patient outcomes including mortality will be recorded. The study will also identify underlying causes of hypomagnesemia including gastrointestinal losses renal dysfunction and drug-induced losses.

Data will be analyzed using SPSS software. Descriptive and inferential statistics will be used to determine prevalence associations and correlations. The study aims to highlight the clinical relevance of magnesium monitoring in ICU sepsis patients to improve patient management outcomes and standard care protocols. There is limited Indian data on this topic and the findings of this study may help bridge this gap and guide further research in critical care electrolyte management.