| CTRI Number |
CTRI/2025/03/082199 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Dysnatremia in critically ill patients. |
|
Scientific Title of Study
|
Incidence and clinical implication of new onset dysnatremia in critically ill patients to ICU in a tertiary care hospital in eastern area. |
| 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. Sagarika Panda |
| Designation |
Associate Professor |
| Affiliation |
IMS AND SUM HOSPITAL, Bhubaneswar |
| Address |
Department OF Critical Care Medicine, IMS AND SUM HOSPITAL, Kalinga Nagar
Khordha
ORISSA
751003
India |
| Phone |
7500340205 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sagarika Panda |
| Designation |
Associate Professor |
| Affiliation |
IMS AND SUM HOSPITAL, BHUBANESWAR |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, IMS AND SUM HOSPITAL, KALINGA NAGAR
ORISSA
751003
India |
| Phone |
7500340205 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anushapreethi S |
| Designation |
DM Resident |
| Affiliation |
IMS AND SUM HOSPITAL, BHUBANESWAR |
| Address |
Department Of Critical Care Medicine, IMS AND SUM HOSPITAL, Kalinga Nagar
ORISSA
751003
India |
| Phone |
7500340205 |
| Fax |
|
| Email |
anushapreethi87@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS And SUM Hospital, Kalinga Nagar, Bhubaneswar-751003 |
|
|
Primary Sponsor
|
| Name |
Anushapreethi S |
| Address |
IMS And SUM Hospital, Kalinga Nagar, Bhubaneswar- 751003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ANUSHAPREETHI S |
IMS AND SUM HOSPITAL |
Department Of Critical Care Medicine
Khordha
ORISSA |
07500340205
anushapreethi87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICSE, INSTITUTE OF MEDICAK SCIENCES (IMS) AND SUM HOSPITAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E871||Hypo-osmolality and hyponatremia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients admitted to the ICU for conditions other than primary sodium disorders. |
|
| ExclusionCriteria |
| Details |
Patients admitted to the ICU primarily due to a sodium disorder.
Patients receiving 3%sodium chloride for cerebro-protective strategy
Patients under 18 years of age, pregnant women, and those with end-stage renal disease on chronic dialysis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the impact of incidental sodium disorders on 28-day mortality of critically ill patients. |
till 28 days ICU stay or death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determine the prevalence and progression of sodium disorders.
1. Length of ICU stay, fluctuations in sodium level |
till 28 days ICU stay or death or discharge |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2025 |
| Date of Study Completion (India) |
30/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Phase 1: Observational
Collect baseline data on serum sodium at ICU admission and
monitor daily sodium levels.
Classify sodium disorders as mild, moderate, or severe.
Phase 2: Interventional
Apply sodium management protocols tailored to each severity
category.
Definitions of Sodium Disorders
Mild: Serum sodium levels between 125 to 150 mEq/L or a deviation
of less than 10 mEq/L from the normal range.
Moderate: Serum sodium levels between 115 to 125 mEq/L or 150 to
160 mEq/L, or a deviation of 10 to 20 mEq/L from the normal range.
Severe: Serum sodium levels below 115 mEq/L or above 160 mEq/L,
or a deviation of more than 20 mEq/L from the normal range.
Monitor outcomes such as mortality, ICU stay length
Primary Outcomes: Mortality rate and major
complication rates.
Secondary
Outcomes: Length of ICU stay, sodium level fluctuations
Until ICU discharge or death |