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CTRI Number  CTRI/2022/07/044056 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 18/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Pre and post surgery Ultrasound Doppler derived Renal Resistive index to predict kidney injury after liver transplant surgery. 
Scientific Title of Study   Perioperative Doppler derived Renal Resistive Index (RRI) as a predictor of Acute Kidney Injury (AKI) after Living Donor Liver Transplantation (LDLT). A prospective 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 Saravanan M 
Designation  Senior Resident DM Resident 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anaesthesia and Intensive Care Institute of Liver and Biliary Sciences Vasant Kunj D1 NEW DELHI

South
DELHI
110070
India 
Phone  9789560136  
Fax    
Email  dr.saravanan92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivali Panwar 
Designation  Consultant and Associate Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anaesthesia and Intensive Care Institute of Liver and Biliary Sciences Vasant Kunj D1 NEW DELHI

South
DELHI
110070
India 
Phone  9818241779  
Fax    
Email  shivalipanwar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saravanan M 
Designation  Senior Resident DM Resident 
Affiliation  institute of liver and biliary sciences 
Address  Department of Anaesthesia and Intensive Care Institute of Liver and Biliary Sciences Vasant Kunj D1 NEW DELHI

South
DELHI
110070
India 
Phone  9789560136  
Fax    
Email  dr.saravanan92@gmail.com  
 
Source of Monetary or Material Support  
Institute of Liver and Biliary sciences vasant kunj New Delhi 
 
Primary Sponsor  
Name  Institue of Liver and Biliary Sciences ILBS 
Address  Department of Anaesthesia and Intensive Care Institute of Liver and Biliary Sciences Vasant Kunj D1 NEW DELHI 
Type of Sponsor  Research institution and hospital 
 
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 SARAVANAN M  Institute of Liver and Biliary Sciences ILBS  Department of Anaesthesia and Intensive Care Institute of Liver and Biliary Sciences Vasant Kunj D1 NEW DELHI 110070
South
DELHI 		 9789560136

dr.saravanan92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ILBS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K745||Biliary cirrhosis, unspecified, (2) ICD-10 Condition: K740||Hepatic fibrosis, (3) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (4) ICD-10 Condition: K743||Primary biliary cirrhosis, (5) ICD-10 Condition: K744||Secondary biliary cirrhosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age 18 to 65 years who will be undergoing Living Donor Liver Transplantation in Institute of Liver and Biliary sciences during the study period. 
 
ExclusionCriteria 
Details  patient refusal, acute liver failure patients undergoing liver transplant, patients with pre-op Hepatorenal syndrome or Acute Kidney Injury in last 7 days or chronic renal failure, patients with renal artery stenosis, refractory ascites, patients undergoing redo-LDLT for graft failure and patients with poor echogenicity - inability to view kidney by ultrasound. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether preoperative and elevated postoperative Renal Resistive Index (RRI) predicts the post liver transplant Acute Kidney Injury  Renal Resistive Index will be done on the day before surgery and on post-operative day 1 and 2. patient will be followed up upto 14 days for any development of AKI. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of MELD Na score, duration of surgery, duration of warm and cold ischaemia time, blood loss and transfusion, amaount and type of fluid replacement, duration of IVC cross clamp, post reperfusion syndrome on the incidence of AKI.
To find the incidence of AKI following liver transplant.
To assess the ability of percentage RI to predict postoperative AKI.
To determine the cut off value of postoperative RRI to predict AKI.
TO find the inter-observer variablity of RRI 		 14 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2022 
Date of Study Completion (India) 28/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Liver transplant surgery is commonly associated with post-operative acute kidney injury (AKI), leading to prolonged Intensive Care Unit/Hospital stay and significant morbidity. The causes of postoperative acute kidney injury (AKI) are multifactorial, including hepatic decompensation of recipients, diabetes mellitus, poor donor graft quality, intraoperative hemodynamic instability, blood loss and blood product transfusions, and nephrotoxic drug administration. Early diagnosis of AKI leading to implementation of reno-protective strategies can significantly improve clinical outcomes in LT recipients. One of the cardinal features of AKI is intrarenal vasoconstriction, which leads to renal hypoperfusion and subsequent manifestations of AKI, including oliguria and elevated serum creatinine. Authors have previously shown a definitive role for ultrasound doppler–derived renal artery resistive index, also called renal resistive index (RRI), in predicting AKI following major cardiac and orthopedic procedures. We seek to investigate the role of RRI in identifying patients developing post-LT AKI. We postulate that regular monitoring of RRI in our LT recipients would help us identify these patients. 
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