| 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
|
|
|
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
|
|
|
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. |