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CTRI Number  CTRI/2022/04/042099 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 26/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Single Arm Study 
Public Title of Study   Fluid responsiveness in liver transplant patients after tidal volume challenge test 
Scientific Title of Study   Tidal volume challenge to predict fluid responsiveness in liver transplant recipients ventilated using low tidal volume 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganesh Ramaji Nimje 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Hospital and Medical College, Jaipur 
Address  Department of Organ Tranplant Anaesthesia and Critical Care, Second Floor, Main Building, Mahatma Gandhi Hospital, Sitapura, Jaipur
nil
Jaipur
RAJASTHAN
302022
India 
Phone  9503332784  
Fax    
Email  ganesh.nimje8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh Ramaji Nimje 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Hospital and Medical College, Jaipur 
Address  Department of Organ Tranplant Anaesthesia and Critical Care, Second Floor, Main Building, Mahatma Gandhi Hospital, Sitapura, Jaipur
nil
Jaipur
RAJASTHAN
302022
India 
Phone  9503332784  
Fax    
Email  ganesh.nimje8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ganesh Ramaji Nimje 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Hospital and Medical College, Jaipur 
Address  Department of Organ Tranplant Anaesthesia and Critical Care, Second Floor, Main Building, Mahatma Gandhi Hospital, Sitapura, Jaipur
nil
Jaipur
RAJASTHAN
302022
India 
Phone  9503332784  
Fax    
Email  ganesh.nimje8@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital & Medical College, Jaipur, Rajasthan 
 
Primary Sponsor  
Name  Mahatma Gandhi Hospital and Medical College  
Address  Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Ramaji Nimje   Mahatma Gandhi Hospital and Medical College  Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9503332784

ganesh.nimje8@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K721||Chronic hepatic failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Patients with chronic liver disease undergoing liver transplantation
-Age group of 18-60 years
-Patient with written informed consent
 
 
ExclusionCriteria 
Details  -Patient refusal
-Cadaveric donor liver transplantation
-Recurrent cardiac arrhythmia
-Reduced ventricular systolic function - left (ejection fraction <40%)
-BMI more than 30
-Intra-operative use of vasopressors or inotropes before or during VTC
-Chronic lung disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine efficacy of PPV and SVV changes after tidal volume challenge in predicting fluid responsiveness in a liver transplant recipient under general anaesthesia with lung protective ventilation.  Time point- After induction of anaesthesia, the tidal volume Challenge (VTC) test will be performed when patient develop hypotension (fall in Systolic Arterial Pressure 20 % from the baseline / MAP below 65 mm/Hg) prior to administration of fluid bolus or any vasopressor agents. Only the data obtained from the first fluid challenge administered to each enrolled patient will be used for the analysis. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Not Applicable 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) 22/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

•      Fluid administration is the first line of treatment in patients with acute circulatory failure.

•      Fluid responsiveness [i.e. the increase in stroke volume (SV) after a fluid challenge] is limited to about 50% of critically ill or surgical patients.

•      Static indexes, such as central venous pressure and pulmonary wedge pressure, are unsuited for this purpose

•      But the dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), reliably predict the effect of fluid challenge administration during controlled mechanical ventilation when a tidal volume (VT) of at least 8 ml/kg is used.

•      Use of an intra-operative lung-protective ventilation strategy (VT of < 8 ml/kg predicted body weight, PBW) is now suggested as standard practice in the operating room.

•      Such small VTs limit the assessment of fluid responsiveness in surgical patients by means of dynamic indexes.

•      To overcome this Myatra et al. recently proposed a new fluid responsiveness test called “the tidal volume challenge”.

•      They demonstrated that an increase in the absolute value of PPV ≥3.5% induced by a transient increase in tidal volume from 6 to 8 mL/kg for 1 minute could reliably predict the increase in cardiac output in response to a fluid bolus performed at a tidal volume of 6 mL/kg whereas the PPV value obtained at 6 mL/kg tidal volume was unreliable for this purpose.

•      Similar results were found for stroke volume variation (SVV) -threshold value: 2.5%

•      Thus, using a tidal volume challenge might overcome the limitations of PPV as a predictive index of fluid responsiveness during low tidal volume ventilation.

•      Recently Messina A et al.  also demonstrate that the

•      changes in PPV and SVV obtained after the Tidal Volume Challenge are reliable and comparable to the changes in CI and SVI obtained after EEOT performed at 8 ml kg PBW in predicting fluid responsiveness in neurosurgical patients.

Therefore, we designed this study to assess the sensitivity and specificity of PPV and SVV changes after tidal volume challenge in predicting fluid responsiveness in a liver transplant recipient under general anaesthesia with lung-protective ventilation

Methodology

•      After approval of the study by the institutional ethical committee & obtaining written informed consent patients posted for liver transplant surgery will be included in the study.

•      In all patients standard intra-operative monitoring, including heart rate, peripheral oxygen saturation, continuous electrocardiography, and non-invasive blood pressure monitoring will be attached

•      Induction agents: Fentanyl 2 mcg/kg, Propofol 1-2 mg/kg, cisatracurium besilate 0.15 to 0.2 mg/kg

•      Maintaince Agents: O2+ Air+ Isoflurane+ Intermittent cisatracurium

•      Ventilatory Setting: Mode- Volume control, Tidal Volume- 6 ml/kg PBW, PEEP- 5, ETCO2- 30-40, SpO2>96

•      PBW (kg) was calculated as follows: X + 0.91[height (cm) - 152.4]; (X = 50 for men and 45.5 for women)

•      After Induction: 7.5 Fr triple lumen line inserted in the right internal jugular vein & invasive blood pressure monitoring will be obtained by inserting a 20-G cannula into the radial artery.

•      Hemodynamic monitoring is done by attaching the FlowTrac system to the patient

•      These are routinely done procedures during liver transplants.

•      Baseline hemodynamic parameters like Pulse Rate (PR), Mean arterial blood pressure(MAP), Central Venous Pressure(CVP),Stroke Volume(SV), Stroke Volume Index (SVI), Cardiac Index(CI), Stroke Volume Variation(SVV), Pulse Pressure Variation(PPP) will be recorded.

The tidal volume Challenge (VTC) test will be performed when the patient develops hypotension (fall in Systolic Arterial Pressure > 20 % from the baseline / MAP below 65 mm/Hg) prior to administration of fluid bolus or any vasopressor agents. Before tidal volume challenge hemodynamic parameters like Pulse Rate (PR), Mean arterial blood pressure (MAP), Central Venous Pressure(CVP), Stroke Volume(SV), Stroke Volume Index (SVI), Cardiac Index(CI), Stroke Volume Variation(SVV), Pulse Pressure Variation(PPP) will be recorded. The “tidal volume challenge” will be performed by transiently increasing tidal volume (VT) (from 6 up to 8 mL/kg PBW for 1 minute), and another set of hemodynamic measurements including the PPV (PPV8) and SVV (SVV8) will be recorded after 1 minute. Additionally, the changes in the value of PPV and SVV (ΔPPV6 − 8 = PPV8 – PPV6 and ΔSVV6 − 8 = SVV8 – SVV6) will be calculated. The tidal volume will be reduced back to 6 ml/kg PBW with the completion of TVC and hemodynamic parameter will be recorded. After that fluid challenge(FC) will be achieved by infusing 250 ml of plasmalyte solution over a period of 10 mins and set of hemodynamic measurements will be recorded. Patients will be classified as a responder if there is an increase in Stroke Volume Index (SVI) by more than 10 % after fluid challenge.  Only the hemodynamic data obtained from the first fluid challenge administered to each enrolled patient will be used for the analysis. For the safety of the patient, the interruption of the protocol will be at the discretion of the attending anaesthetist.

 
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