| CTRI Number |
CTRI/2025/07/091519 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using leg raise and heart ultrasound to see if patients need more fluids |
|
Scientific Title of Study
|
Assessment of fluid responsiveness by analyzing stroke volume change with Transthoracic echocardiography on passive leg raising test in hemodynamically unstable 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 |
Dr Harsh Kumar |
| Designation |
PG Resident |
| Affiliation |
ESIC Hospital And PGIMSR |
| Address |
Department of Anaesthesia ESIC-PGIMSR Basaidarapur New Delhi
West
DELHI
110015
India |
| Phone |
8920779444 |
| Fax |
|
| Email |
Shakywarharsh1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Sethi |
| Designation |
Professor |
| Affiliation |
ESIC Hospital And PGIMSR |
| Address |
Department of Anaesthesia ESIC-PGIMSR Basaidarapur New Delhi
West
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Sethi |
| Designation |
Professor |
| Affiliation |
ESIC Hospital And PGIMSR |
| Address |
Department of Anaesthesia ESIC-PGIMSR Basaidarapur New Delhi
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC PGIMSR Basaidarapur New Delhi 110015 India |
|
|
Primary Sponsor
|
| Name |
Dr Harsh Kumar |
| Address |
Department of Anaesthesia ESIC-PGIMSR Basaidarapur New Delhi 110015 India |
| 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 Harsh Kumar |
ESIC Hospital And PGIMSR |
Department of anaesthesia
West
DELHI |
08920779444
Shakywarharsh1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ESI-PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients or Relatives willing to give consent,
Hemodynamically unstable patients,
Mean arterial pressure less than 65 mmHg,
need for any vasopressor or ionotropic support, blood lactate levels more than 2 mmol per litre, urine output less than 0.5mlper kg per hr for more than 2hr,
tachycardia more than 100 bpm,
Signs of hypoperfusion.
|
|
| ExclusionCriteria |
| Details |
Poor cardiac echogenicity,
Cardiac arrythmias at the time of study,
Aortic valve disease,
Contraindications of PLR (Intracranial hypertension, Intra-abdominal hypertension), Venous stasis (DVT),
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare changes in Stroke Volume
in response to fluid challenge and passive leg raising |
baseline, 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measure & compare percentage changes in mean value, in response to the PLR test & FC test in mean arterial pressure |
baseline , 15 minutes |
| Measure & compare percentage changes in mean value, in response to the PLR test & FC test in ejection fraction |
baseline , 15 minutes |
| Measure & compare percentage changes in mean value, in response to the PLR test & FC test in heart rate |
baseline , 15 minutes |
| Measure & compare percentage changes in mean value, in response to the PLR test & FC test in IVC diameter |
baseline , 15 minutes |
| Measure & compare percentage changes in mean value, in response to the PLR test & FC test in Cardiac Index |
baseline , 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
01/08/2026 |
| 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="5"
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
|
Hemodynamic instability in critically ill patients often prompts fluid resuscitation, yet overzealous fluid administration risks pulmonary edema, intracranial hypertension, and cardiac overload. Traditional static measures like CVP and PAOP poorly predict whether a patient’s cardiac output will actually improve after fluids, whereas dynamic assessments like stroke volume variation, pulse pressure variation, and especially passive leg raising offer greater sensitivity and specificity. PLR transiently increases preload by shifting venous blood centrally, acting as a reversible, noninvasive self-fluid challenge, and a 10 to 15 percent rise in stroke volume during PLR reliably identifies fluid responders. Transthoracic echocardiography, by measuring LVOT velocity time integral before and after PLR and combining SV changes with cardiac index and IVC collapsibility provides real time,risk free evaluation of fluid responsiveness. This study hypothesizes that PLR induced SV changes measured by TTE can accurately predict which hemodynamically unstable patients will benefit from fluid administration |