| CTRI Number |
CTRI/2026/03/105169 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using a leg raise test to guide fluid treatment in critically ill patients |
|
Scientific Title of Study
|
Evaluation of passive leg raise test as a predictor of fluid responsiveness in critically ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANURAG |
| Designation |
Postgraduate resident |
| Affiliation |
VMMC and safdarjung hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung hospital, Ansari nagar east , new delhi
South
DELHI
110029
India |
| Phone |
8920800688 |
| Fax |
|
| Email |
anuragflux@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti thakur |
| Designation |
Associate professor |
| Affiliation |
VMMC and safdarjung hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung hospital, Ansari nagar east , new delhi
South
DELHI
110029
India |
| Phone |
919971872999 |
| Fax |
|
| Email |
preetideepak268@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti thakur |
| Designation |
Associate professor |
| Affiliation |
VMMC and safdarjung hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung hospital, Ansari nagar east , new delhi
South
DELHI
110029
India |
| Phone |
919971872999 |
| Fax |
|
| Email |
preetideepak268@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung hospital, Ansari nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung hospital, Ansari nagar east , new delhi |
| 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 Anurag |
VMMC and Safdarjung hospital |
Department of anaesthesia and intensive care , VMMC and Safdarjung hospital, Ansari nagar east , New Delhi
South
DELHI |
8920800688
anuragflux@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EVALUATION OF PASSIVE LEG RAISE TEST |
Evaluating a Simple Bedside Test to Predict Fluid Response in Critically Ill Patients |
| Comparator Agent |
Fluid response test |
Giving 200ml fluid in critical ill patient by doing Ultrasonography |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients on mechanical ventilation admitted to ICU with either of following features-
Systolic blood pressure less than 90mmHg
Mean blood pressure less than 65mmHg
Patients on vasopressors
Patients with urine output less than 0.5ml/kg/hr for atleast 2 hours |
|
| ExclusionCriteria |
| Details |
1. Known cases of acute or chronic kidney disease
2. Known cases of congestive cardiac failure
3. Known cases of raised intracranial tension, valvular heart disease, cardiomyopathy.
4. Pregnant patients
5. Patients with abdominal distension and open abdomen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Left ventricle- velocity time integral |
After 1 min of passive leg raise and after 5 min of volume expansion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters |
After 1 min of passive leg raise & after 5 min of volume expansion |
|
|
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)
|
10/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In the management of critically il patients, the assessment of volume responsiveness and the decision to •administer a fluid bolus constitute a common dilemma for physicians. Static indices of cardiac preload are poor predictors of volume responsiveness. Passive leg raising (PLR) mimics an endogenous volume expansion (VE) that can be used to predict fluid responsiveness. This study was to assess the changes in stroke volume index (SVT) induced by PLR as an indicator of fluid responsiveness in mechanically ventilated patients critically ill Patient |