| CTRI Number |
CTRI/2026/03/105251 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study in liver transplant patients to compare different methods of giving fluids during surgery and their effect on recovery and complications. |
|
Scientific Title of Study
|
Comparative Impact of Standardized Conventional Care, Pulse Pressure Variation-Guided, and Stroke Volume Variation- Guided Fluid Therapy on Total Intraoperative Fluid Administration and Postoperative Outcomes in Liver Transplantation: A Randomized Controlled Trial |
| 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 Ankush Mittal |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No-C5, Department of Anaesthesiology, ILBS Hospital, D1 Vasant Kunj
South
DELHI
110070
India |
| Phone |
7206746001 |
| Fax |
|
| Email |
ankush221096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesiology, Institute of liver and biliary sciences, D1, Vasant Kunj
South
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesiology, Institute of liver and biliary sciences, D1, Vasant Kunj
South
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intitute funding, Department Of Anaesthesia, Institute Of Liver and Biliary Sciences, D1, Vasant kunj, New Delhi, India, Pin code- 110070 |
|
|
Primary Sponsor
|
| Name |
Institute Of Liver and Biliary Sciences |
| Address |
Institute Of Liver and Biliary Sciences, D1, Vasant Kunj |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ankush Mittal |
Institute Of Liver and Biliary Sciences |
Department Of Anaesthesiology and Intensive Care, 3rd floor D-1, Vasant Kunj, New Delhi, India- 110070
South
DELHI |
7206746001
ankush221096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/IRB-ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, (3) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group PPV (PPV-Guided GDFT) |
Continuous PPV monitoring measured from an invasive arterial line PVV monitoring will be used exclusively in this group and will not be available or visible to the treating anesthesiologist in the Standard Care or SVV-guided groups. Fluid algorithm: Target PPV: less than 13 percent If PPV is more than 13 percent in the presence of MAP is less than 65-75 mm of hg: Crystalloid bolus 250 ml over 10 minutes Reassess after each bolus: if PPV is less than 13 percent or MAP improves, withhold further bolus; if PPV remains more than or equal to 13 percent, repeat bolus. Use vasopressors if hypotension persists despite fluid optimisation. |
| Comparator Agent |
Group SCC (Standard Conventional Care) |
Interventions in this group will be multifactorial, with decisions based on a combination of the above parameters rather than a single numeric target, by the attending anaesthesiologist.
SVV and PPV will not be visible or used for routine management in this group; however, in cases of poor hemodynamic response, they may be temporarily unblinded and used as rescue tools to guide fluid or vasopressor therapy for patient safety.
Fluid therapy guided by conventional parameters such as:
Heart rate, arterial pressure trends, urine output, and central venous pressure (CVP)
HR target: within 20 percent of the patient’s preoperative baseline HR
MAP target: more than or equal to 65 mmHg
CVP target: within 2 mmHg of the patient’s pre-induction baseline
Urine output: more than or equal to 0.5 mL per kg per hr
Clinical judgement: bleeding, surgical field, temperature, lactate trends
Boluses: 250 ml crystalloid/colloid based on hypotension or low CVP
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18-65 years) of either sex of American Society of Anesthesiologists (ASA) physical Status III or IV scheduled to undergo elective living donor liver transplantation |
|
| ExclusionCriteria |
| Details |
Cardiac dysfunction such as valvular abnormalities, severe systolic dysfunction, Preexisting severe pulmonary disease, moderate-severe hepatopulmonary syndrome, Acute kidney injury, Acute liver failure, Re-transplantation, Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total intraoperative fluid requirement among PPV-guided, SVV-guided, and standard care-guided fluid therapy in adult patients undergoing liver transplantation. |
at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & severity of post-reperfusion syndrome |
At the end of surgery |
| Vasopressor requirement (total dose, µg per kg per min). |
at the end of surgery |
| Postoperative pulmonary function (e.g., Duration of postop mechanical ventilation, PaO2:FiO2 ratio, need for re-intubation, pulmonary complications such as fluid overload, ARDS or pneumonia) |
immediately postop, 3hr, 12hr, 6hr, 24hr, 48hr postoperatively |
| Post-op liver function (AST, ALT, INR, bilirubin). |
24hr, 48hrs, 72hrs Postoperatively |
| Incidence of acute kidney injury (KDIGO criteria) & serum creatinine levels. |
at 1,2,3,4,5,6,7 days |
| 30-day graft-related complication |
|
| Length of ICU and hospital stay (days) |
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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 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
|
Liver
transplantation is a complex surgical procedure, characterised by major fluid
shifts, significant hemodynamic instability, coagulopathy. Optimal intravascular volume management during
surgery is essential for maintaining organ perfusion, minimising bleeding,
supporting graft function, and preventing postoperative complications. PPV and
SVV are dynamic
preload indices proven to predict fluid responsiveness better than static
markers. Goal directed fluid therapy using PPV/SVV improves outcomes in major
surgeries However, their reliability may be altered by liver transplant physiology
(low SVR, open abdomen, reperfusion events). Limited data exist on
PPV-/SVV-guided therapy specifically in liver transplantation
This is a randomized control study to compare the effectiveness
of Standardized Conventional Care vs Pulse Pressure Variation–Guided vs
Stroke Volume Variation -
Guided
fluid therapy on
total intraoperative fluid administration and postoperative outcomes in adult patients
undergoing orthotopic liver transplantation. Secondary objectives are to compare the different strategies
with regard to Incidence and severity of post-reperfusion syndrome, Vasopressor
requirement (total dose, µg per kg per min), Postoperative pulmonary function
(e.g., Duration of postop mechanical ventilation, PaO2:FiO2 ratio, need for
re-intubation, pulmonary complications such as fluid overload, ARDS or
pneumonia), Postoperative USG Lungs, Post-op liver function (AST, ALT, INR,
bilirubin), Incidence
of acute kidney injury (KDIGO criteria), Length of ICU and hospital stay (days),
30-day graft-related complication and30-day patient mortality.
|