| CTRI Number |
CTRI/2025/07/090338 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to observe the low sodium levels in patients admitted in the intensive care unit |
|
Scientific Title of Study
|
An observational study on prevalence of hyponatremia in intensive care unit. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwin kumar G |
| Designation |
Msc Critical care technology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of Critical Care Medicine porur chennai
Sri Ramachandra Institute of Higher Education and Research
Department of Critical Care Medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7708439564 |
| Fax |
|
| Email |
ashwinkumarak9399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Baby sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of critical care medicine porur chennai
Sri Ramachandra Institute of Higher Education and Research
Department of critical care medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Renuka MK |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of Critical Care Medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher education and Research
Porur-600116
Chennai
India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of critical care medicine
Porur-600116
Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renuka MK |
Sri Ramachandra Institute Of Higher Education and Research |
Department of Critical
Care Medicine
Porur
Ramachandra Nagar
Porur Chennai
600116
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
8056126336
renuka.mk@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E87||Other disorders of fluid, electrolyte and acid-base balance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with above 18 years of age.
More than 48 hours of Intensive Care Unit stay.
Serum sodium levels are measured within 24 hours of admission.
|
|
| ExclusionCriteria |
| Details |
Incomplete medical records or missing serum sodium data.
Below 18 years of age should not be considered.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Risk factors associated with prevalence of hyponatremia in intensive care unit. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the outcomes of hyponatremia in critically ill. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/08/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This observational study investigates the prevalence of hyponatremia among patients admitted to the Intensive Care Unit (ICU). Hyponatremia is defined as a serum sodium level below 135 mmol/L is a common electrolyte imbalance in critically ill patients and can significantly affect morbidity and mortality. The study collects data on serum sodium levels demographic details underlying conditions and clinical outcomes to determine how frequently hyponatremia occurs in ICU settings and its association with disease severity and prognosis. Findings aim to raise awareness and guide better management strategies for hyponatremia in critical care. |