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CTRI Number  CTRI/2026/01/101960 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Ability of Blood Pressure and Central Venous Pressure Changes in knowing the Fluid bolus response in Septic Shock patients 
Scientific Title of Study   Diagnostic performance of Combined Central Venous Pressure and Pulse Pressure changes during fluid challenges for predicting Fluid Responsiveness in Septic Shock 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namitha Mariam Lal 
Designation  Senior Resident (Acad) 
Affiliation  AIIMS Guwahati 
Address  Dept of Anesthesiology, Critical Care, and Pain Medicine, AIIMS Guwahati, Changsari

Kamrup
ASSAM
781101
India 
Phone  8289884011  
Fax    
Email  namithamariamlal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Habib Md Reazaul Karim 
Designation  Additional Professor 
Affiliation  AIIMS Guwahati 
Address  Dept of Anesthesiology, Critical Care, and Pain Medicine, AIIMS Guwahati, Changsari

Kamrup
ASSAM
781101
India 
Phone  9612372585  
Fax    
Email  drhabibkarim@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anirban Bhattacharjee 
Designation  Assistantl Professor 
Affiliation  AIIMS Guwahati 
Address  Dept of Anesthesiology, Critical Care, and Pain Medicine, AIIMS Guwahati, Changsari

Kamrup
ASSAM
781101
India 
Phone  8014076629  
Fax    
Email  onir.bhatt@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS) Guwahati 
 
Primary Sponsor  
Name  AIIMS Guwahati 
Address  Changsari, Assam 781101  
Type of Sponsor  Government medical college 
 
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 
Dr Habib Md Reazaul Karim  Intensive Care Unit  Second Floor, IPD Building, AIIMS Guwahati Hospital, Changsari, Assam. PIN- 781101
Kamrup
ASSAM 
9612372585

drhabibkarim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Guwahati Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
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  Invasive mechanical ventilation
Having septic shock
Fluid challenge is indicated
presence of central and arterial line for management
On norepinephrine less than 0.3 mcg/kg/min and dose unchanged in last 5 minutes
RASS less than or equal to -1 
 
ExclusionCriteria 
Details  Poor echocardiography window
Known case of mitral or aortic regurgitation
Evidence of acute cor pulmonale or right ventricular failure
Obvious severe hypovolemia
Requirement of more than 1 vasopressor or inotrope
•Uncontrolled arrhythmia other than sinus tachycardia/bradycardia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare the accuracy of combined changes in central venous pressure (CVP) and pulse pressure (PP) during a standardized fluid challenge to predict fluid responsiveness (FR), against change in left ventricular outflow tract velocity–time integral (LVOT VTI)  0, 1 min 
 
Secondary Outcome  
Outcome  TimePoints 
1. Accuracy of delta CVP for predicting fluid responsiveness
2. Accuracy of Delta PP for predicting fluid responsiveness
3. Assessment of the association between delta CVP and delta PP categories and fluid responsiveness after adjusting for co-variates 
0. 1 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/02/2026 
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="2"
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  

This is a prospective observational study conducted in a mixed medical surgical intensive care unit to assess the usefulness of routinely available hemodynamic parameters for predicting fluid responsiveness in adult patients with septic shock. Adult mechanically ventilated patients with septic shock who have a central venous catheter and invasive arterial blood pressure monitoring and are receiving stable low dose noradrenaline will be included when a fluid challenge is clinically indicated as part of standard care. A standardized fluid bolus of 250 ml crystalloid will be administered over ten minutes. Changes in central venous pressure pulse pressure and echocardiographic left ventricular outflow tract velocity time integral will be recorded immediately before and after the fluid challenge. Fluid responsiveness will be defined as a ten percent or greater increase in velocity time integral. The study will evaluate the diagnostic accuracy of combined changes in central venous pressure and pulse pressure for predicting fluid responsiveness using appropriate statistical models accounting for repeated measurements. The findings of this study are expected to help identify a simple practical and cost-effective approach to guide fluid therapy in intensive care units especially in resource limited settings.

 
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