| CTRI Number |
CTRI/2025/11/097446 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how raising the legs affects heart function in patients with and without liver disease using an ultrasound of the heart. |
|
Scientific Title of Study
|
Effect of passive leg raising manoeuvre on the change in cardiac output in cirrhotic and noncirrhotic patients using transthoracic echocardiography. A Prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Sura |
| Designation |
Junior Resident |
| Affiliation |
Post graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Anesthesia Office, Level 4, Block A, Nehru Hospital, Post graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9650699609 |
| Fax |
|
| Email |
manisha.sura.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamal Kajal |
| Designation |
Associate Professor |
| Affiliation |
Post graduate Institute of Medical Education and Research |
| Address |
Anesthesia Office, Level 4, Block A, Nehru Hospital, Post graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamal Kajal |
| Designation |
Associate Professor |
| Affiliation |
Post graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Anesthesia Office, Level 4, Block A, Nehru Hospital, Post graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate Institute of Medical Education and Research, Chandigarh, India, PIN- 160012
|
|
|
Primary Sponsor
|
| Name |
Manisha Sura |
| Address |
Anesthesia Office, Level 4, PGIMER, Chandigarh, 160012 |
| 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 |
| Manisha Sura |
Post graduate Institute of Medical Education and Research |
Liver ICU, Level 2, Nehru Hospital and Main OT complex, Level 4, Nehru Hospital
Chandigarh
CHANDIGARH |
09650699609
manisha.sura.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patients older than 18 years
-Compensated cirrhosis
-Decompensated cirrhosis
-Non- cirrhotic patients
|
|
| ExclusionCriteria |
| Details |
-Unsatisfactory cardiac echogenicity,
-Increase in intra-abdominal pressure suspected by clinical context and examination in non-cirrhotic patients.
-Patients younger than 18 years,
-Body mass index greater than 40 kg/m2 or less than 15 kg/m2,
-Aortic valvopathy.
-Mitral insufficiency greater than grade 2, Mitral stenosis, or intracardiac shunt
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine changes in CO induced by the PLR manoeuvre |
Baseline[Before PLR], During PLR, After PLR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of PLR on
1.Heart rate
2.Systolic arterial pressure
3.Diastolic arterial pressure
4.Mean arterial pressure
5.IVCD
6.IVCCI
7.Stroke volume (LVOT –VTI)
|
Baseline[Before PLR], During PLR, After PLR |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/11/2025 |
| 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)
|
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
|
Optimal fluid management is essential for maintaining hemodynamic stability during anesthesia and surgery. Assessing fluid responsiveness helps guide fluid therapy and prevent both hypovolemia and fluid overload. In patients with liver cirrhosis, altered cardiovascular physiology makes prediction of fluid responsiveness challenging. This prospective observational study aims to evaluate the effect of a passive leg raising (PLR) manoeuvre on cardiac output in cirrhotic and non-cirrhotic patients, using transthoracic echocardiography (TTE). Adult patients aged 18 to 65 years will be enrolled and divided into cirrhotic and non-cirrhotic groups. Cardiac output will be measured before and after the PLR manoeuvre to assess preload responsiveness. The primary outcome will be the percentage change in cardiac output following PLR in both groups. The study seeks to determine whether cirrhosis alters the hemodynamic response to PLR. The results may provide useful information for optimizing perioperative fluid management in cirrhotic and non-cirrhotic patients. |