| CTRI Number |
CTRI/2025/06/089816 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare ultrasound guided volume status parameters with blood pressure variables in predicting whether a patient with fall in blood pressure will respond to giving fluid or not. |
|
Scientific Title of Study
|
Comparison of Pulse Pressure Variation, Inferior Vena Cava Distensibility Index, Hemodynamics and Changes in Hemodynamics in Response to Mini Fluid Challenge as Predictor of Fluid Responsiveness. |
| 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 Ruchi Gupta |
| Designation |
Consultant |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine Holy Family Hospital
Okhla Road
New Delhi
South
DELHI
110025
India |
| Phone |
9910695602 |
| Fax |
|
| Email |
ruchi_gupta.mamc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine Holy Family Hospital
Okhla Road
New Delhi
South
DELHI
110025
India |
| Phone |
9910695602 |
| Fax |
|
| Email |
ruchi_gupta.mamc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Ray |
| Designation |
Medical Director and Head of Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
New Delhi
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Holy Family Hospital
Okhla Road
New Delhi-110025
India |
|
|
Primary Sponsor
|
| Name |
Dr Ruchi Gupta |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi-110025
India
New Delhi |
| 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 Ruchi Gupta |
Holy Family Hospital |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi
South
DELHI |
9910695602
research2024.ccm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Holy Family Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R579||Shock, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hemodynamic parameters |
Hemodynamic parameters and changes will be measured pre and post fluid bolus and will include heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse pressure. |
| Intervention |
Inferior Vena Cava Distensibility Index (dIVC) |
A second observer trained in critical care ultrasound will note inferior vena cava using Philips CX50 portable ultrasound with a low frequency phased array probe( 1-5MHz).The probe will be placed subcostally and diameter of IVC is measured in longitudinal section 1 cm distal to junction of hepatic vein to IVC in the M mode. The minimum and maximum diameter in a respiratory cycle will be noted. Three readings will be taken and average calculated. IVC distensibilty index (DIVC) will be calculated |
| Comparator Agent |
Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) |
A third observer trained in critical care ultrasound will measure Left ventricular outflow tract velocity time integral (LVOT VTI) in an apical 5 chambers cavity window with a low frequency phased array probe( 1-5MHz). LVOT VTI will be used as surrogate for stroke volume
A Fluid challenge of 4ml/kg of predicted body weight will be infused over 1-2 mins. Fluid bolus will be stopped in case of rapidly rising oxygen requirement. Post fluid challenge, LVOT VTI will be again measured. A 10% rise in LVOT VTi will be taken as fluid responders. Absolute hemodynamic parameters and changes following fluid bolus, IVC distensibility index and pulse pressure variation will be compared to predict fluid responsiveness. |
| Intervention |
Pulse Pressure Variation (PPV)
|
For evaluating ability to predict fluid responsiveness. PPV is recorded using Philips Intellivue MX430 patient multipara monitor as an automated percentage value from the arterial waveform of the invasive arterial blood pressure tracing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. More than or equal to 18 years of age on mechanical ventilation admitted in ICU
2. Clinical signs of shock, defined as any of the following:
a.MAP less than 65mmHg
b.Requiring vasopressors support to maintain MAP more than 65mmHg
c.Lactate more than 2mmol per L
d.Oliguria less than 0.5ml per kg per hour urine output
e.Capillary refill time more than 5sec.
|
|
| ExclusionCriteria |
| Details |
1.Cardiac arrythmias
2.Moderate to severe valvular dysfunction
3.Poor echo window
4.Increased intraabdominal pressure
5.Large intra-abdominal masses or ascites causing IVC compression.
6.Right heart failure, acute Cor pulmonale
7.Patient not giving consent to get included in study.
8.Spontaneous breathing efforts (interferes with heart-lung interaction).
9.Severe obstructive airway diseases (e.g., COPD exacerbation, asthma with active bronchospasm).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive power of Pulse Pressure Variation (PPV) and the Distensibility Index of the Inferior Vena Cava (DIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock. |
Before and after completion of fluid bolus. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive power of PPV and DIVC as dynamic parameters for prediction of fluid responsiveness among responders and non-responders. |
Pre fluid challenge |
| To analyze the changes in hemodynamic parameters after a fluid challenge and their association with fluid responsiveness |
pre and post fluid challenge |
To assess the predictive performance of PPV and DIVC across subgroups, such as:
1.Septic vs. non-septic shock patients.
2.Patients with varying vasopressor (norepinephrine equivalent) requirements.
|
prefluid challenge |
| To determine the impact of baseline clinical and hemodynamic variables, such as central venous pressure (CVP) and baseline vasopressor support, on fluid responsiveness. |
prefluid challenge |
| To validate the reliability of PPV and DIVC under varying clinical conditions, such as different driving pressures and PEEP levels, through subgroup analyses. |
prefluid challenge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/07/2025 |
| 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)
Modification(s)
|
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
|
This prospective observational cohort study will be conducted in the critical care department at Holy Family Hospital, New Delhi, on patients over 18 years of age with Shock undergoing Mechanical Ventilation. This study aims to compare the effectiveness of hemodynamic parameters, pulse pressure variation (PPV) and inferior venacava distensibility index (dIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock. After obtaining ethics approval and written informed consent, eligible patients will be enrolled. Patients will be sedated, paralyzed, and mechanically ventilated with a tidal volume of 8mL per kg predicted body weight, maintaining a semi-recumbent position.
Baseline hemodynamic parameters (PPV, heart rate, blood pressure, CVP) will be recorded using invasive arterial waveform monitoring. dIVC will be measured via ultrasound at the IVC-hepatic vein junction, and left ventricular outflow tract velocity time integral (LVOT VTI) will be assessed via echocardiography. Observations will be conducted by trained, blinded observers.
A Fluid challenge (4mL/kg) will be administered, and changes in hemodynamic parameters and LVOT VTI will be recorded immediately and 2 minutes post-infusion. Patients will be classified as fluid responders (more than or equal to 10% increase in LVOT VTI) or non-responders (less than 10% increase). Observers will remain blinded throughout the study to minimize bias and variability. Maintenance fluids and treatment will be managed by the treating physician,
|