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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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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