| CTRI Number |
CTRI/2025/02/080429 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of patients with low sodium levels with aspect to clinical profile and outcome. |
|
Scientific Title of Study
|
Study of clinical profile, complications and outcome in patients 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 |
Dr Kajal Gupta |
| Designation |
Junior Resident |
| Affiliation |
DY Patil University |
| Address |
DY Patil Hospital Nerul sector 15 Navi Mumbai. Department of general medicine. intensive care unit second floor
Thane
MAHARASHTRA
400706
India |
| Phone |
7666030760 |
| Fax |
|
| Email |
kajalkuu2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santwana Chandrakar |
| Designation |
Head Of Unit |
| Affiliation |
DY Patil University |
| Address |
DY Patil Hospital Nerul sector 15 Navi Mumbai. department of general medicine. intensive care unit, second floor.
Thane
MAHARASHTRA
400706
India |
| Phone |
9820505489 |
| Fax |
|
| Email |
santwanachandrakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Gupta |
| Designation |
Junior Resident |
| Affiliation |
DY Patil University |
| Address |
DY Patil Hospital Nerul sector 15 Navi Mumbai. Department of genral medicine. intensive care unit, second floor.
Thane
MAHARASHTRA
400706
India |
| Phone |
7507720873 |
| Fax |
|
| Email |
kajalkuu2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil Hospital Nerul sector 15 Navi Mumbai. department of general medicine.Maharashtra,India 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Kajal Gupta |
| Address |
DY Patil university nerul sector 15 |
| 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 Kajal Gupta |
Dr.DY Patil hospital |
Dr.D.Y.Patil Hospital ICU(General Medicine), second floor Dr. D.Y.Patil Hospital Nerul, navi mumbai-400706
Thane
MAHARASHTRA |
750770873
kajalkuu2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedicl and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E871||Hypo-osmolality and hyponatremia, (2) ICD-10 Condition: E871||Hypo-osmolality and hyponatremia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
serum sodium levels less than 135mmol/L |
|
| ExclusionCriteria |
| Details |
1) age less than 18 years
2) pregnant females
3) patients already on treatment for chronic hyponatremia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients with hyponatremia in intensive care unit
2.common symptoms that patients presented with |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| causes of hyponatremia in the presented patients |
1 year |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
23/02/2025 |
| 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="0"
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
|
Study of clinical profile, complications and outcome of patients of hyponatremia in intensive care unit. focus will be on ICU patients, cause of hyponatremia in them and what treatment the patients were given. percentage of patients responded to different types of treatment like NS, 3% nacl, tab Tolvapton, etc. percentage of patients sodium levels became normal and were shifted to wards. percentage of patients developed complications and how many died.
|