| CTRI Number |
CTRI/2024/11/077063 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Role of Passive leg raise reponse In New Onset Sodium abnormality and correlation with sodium correction in neurointensive care unit- Observational Study |
|
Scientific Title of Study
|
Role of Fluid Response Assessment In New Onset Hyponatremia and correlation with sodium correction in critically ill neurological patients- A Prospective Observational 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 |
Rohini M Surve |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
Department of Neuroanaestthesia and Neurocritical care, National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
96202166554 |
| Fax |
|
| Email |
rohinigondhule@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rohini M Surve |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
| Address |
Department of Neuroanaestthesia and Neurocritical care, National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
96202166554 |
| Fax |
|
| Email |
rohinigondhule@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rohini M Surve |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
Department of Neuroanaestthesia and Neurocritical care, National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
96202166554 |
| Fax |
|
| Email |
rohinigondhule@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India, 560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Hosur road, Bengaluru |
| 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 |
| Deepak G P |
National Institute of Mental Health and Neurosciences |
Department of Neuroanaesthesia and neurocritical care, NIMHANS, Hosur road, Bangalore Bangalore KARNATAKA |
9164339461
Deepuganjigere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
. |
|
| ExclusionCriteria |
| Details |
1. Pre-existing sodium abnormalities/ on treatment before admission.
2. Patients with inotropes or vasopressor
3. Patients with end-stage renal disease or on dialysis.
4. Patients with chronic liver disease.
5. Patients with congestive heart failure, and cardiac pathology.
6. Patients with raised ICP
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in 24 hour sodium |
1. 24 hour
2. 48 hour
3. 72 hour
4. 96 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
nil |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
30/11/2024 |
| 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) |
Open to Recruitment |
|
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
|
Hyponatremia
is the most common electrolyte disorder in patients admitted to the
neuro-intensive care unit (NICU). The incidence of hyponatremia is 38-50% in
NICUs and can significantly affect patient outcomes. The etiology and treatment
strategies for correcting hyponatremia are often related to the patient’s
volume status. The intensivists often judge the
patient’s volume status by clinical assessment and the information from the
inferior vena cava (IVC) diameter measurement. However, with this, it may be difficult to
differentiate between hypovolemia and euvolemia. Use
of dynamic measures such as stroke volume variation (SVV) or pulse pressure
variation by pulse contour analysis method are also employed to understand the
volume status, however, the cardio-pulmonary interactions pose a significant
limitation to the interpretation of underlying volume status . These methods are often misleading and
thus addressing the underlying volume status even more challenging. The
assessment of fluid responsiveness by a fluid challenge (FC) or the passive leg
raise (PLR)-induced stroke volume (SV) change, can also be monitored with
non-invasive cardiac output (CO) monitor (NICOM). The operating principle of
NICOM is the bioreactance to the applied current to the thorax, which is devoid
of heart-lung interaction and can thus be well utilised in spontaneously
breathing patients. This modality has been observed as a reliable indicator of
volume status, including in patients with sepsis, and found to be safe in
guiding fluid administration and may improve outcomes . However, the application of the
assessment of fluid responsiveness using the NICOM has not been studied in
patients with hyponatremia. This
study aims to assess the volume status using PLR response in patients admitted
to NICU and who develops new-onset sodium abnormalities. The findings of this
study shall help to better understand the underlying mechanisms and guide
appropriate management strategies. |