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CTRI Number  CTRI/2022/04/042038 [Registered on: 21/04/2022] Trial Registered Prospectively
Last Modified On: 11/05/2023
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 renal transplant patients after tidal volume challenge test 
Scientific Title of Study   Assessment of Fluid Responsiveness after Tidal Volume Challenge in Renal Transplant Recipients: A Prospective Observational Study 
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  Professor Quarter Type IIA 004 Mahatma Gandhi Hospital and Medical College Sitapura Jaipur

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  Professor Quarter Type IIA 004 Mahatma Gandhi Hospital and Medical College Sitapura Jaipur

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  Professor Quarter Type IIA 004 Mahatma Gandhi Hospital and Medical College Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9503332784  
Fax    
Email  ganesh.nimje8@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital and Medical College 
 
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 
09503332784

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: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Patients of end-stage renal disease undergoing renal transplantation
-Age group of 18-60 years
-Patient with written informed consent
 
 
ExclusionCriteria 
Details  -Patient refusal
-Cadaveric donor renal 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 renal transplant recipient under general anaesthesia with lung protective ventilation.  The tidal volume Challenge (TVC) test will be performed when patient develop hypotension (fall in Systolic Arterial Pressure 20 % from the baseline / MAP below 70 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  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2022 
Date of Study Completion (India) 01/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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. Dedicated algorithms and protocols of anaesthetic care regarding fluid therapy are key factors to prevent perioperative hypovolaemia or hypervolaemia, which are both known to increase morbidity and length of hospital stay.  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. For this reason, fluid challenge administration should be based on predictors of fluid responsiveness. 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 associated with a better outcome and 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 VT-related limitation of PPV and SVV, the prediction of fluid responsiveness can be achieved by applying functional haemodynamic tests aimed at increasing venous return and enhancing right ventricle preload dependence. Among these, the interruption of positive pressure ventilation (the so-called end-expiratory occlusion test, EEOT), initially proposed in critically ill patients, has been tested in two studies of elective surgical patients, with conflicting results. In patients ventilated with a mean VT of 8.2 ml/kg, the EEOT was unable to reliably predict fluid responsiveness, while the opposite was demonstrated in patients ventilated with a mean VT of 6.8 ml/kg. 

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) obtained from a contour analysis cardiac output monitor (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 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.

We hypothesised that the baseline reliability of the dynamic indices in elective surgical patients undergoing protective lung ventilation would be enhanced by the use of functional haemodynamic tests. 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 renal transplant recipient under general anaesthesia with lung protective ventilation

 
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