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CTRI Number  CTRI/2025/08/092922 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of fluid therapy in patients undergoing kidney transplantation. 
Scientific Title of Study   Comparison of perioperative protocolized fluid regimen based on ERAS with standard fluid regimen in recipients undergoing kidney transplantation. A Randomised control equivalence 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  Rick Bose 
Designation  Junior resident 
Affiliation  Postgraduate Institute of medical education and research, Chandigarh 
Address  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9830495215  
Fax    
Email  dwirefbose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kamal Kajal 
Designation  Additional professor, Postgraduate Institute of Medical Education and research, Chandigarh  
Affiliation  Postgraduate Institute of medical education and research, Chandigarh 
Address  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9560412726  
Fax    
Email  kamal.kajal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kamal Kajal 
Designation  Additional professor, Postgraduate Institute of Medical Education and research, Chandigarh  
Affiliation  Postgraduate Institute of medical education and research, Chandigarh 
Address  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9560412726  
Fax    
Email  kamal.kajal@gmail.com  
 
Source of Monetary or Material Support  
PGIMER INSTITUTE, CHANDIGARH-160012 INDIA 
 
Primary Sponsor  
Name  Postgraduate Institute of medical education and research  
Address  PGIMER, Sector 12, chandigarh, pin-160012 
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 Kamal Kajal  PGIMER   Department of anaesthesia and intensive care,Sector 12
Chandigarh
CHANDIGARH 
09560412726

kamal.kajal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER 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, (2) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  fluid regimen   First 6 hours post op replace fluid equal to output. After 6 hours as per reduction protocol. Output in ml per hour Reduction 2000 or more 500 1500 to 1900 400 1200 to 1400 300 900 to 1100 200 700 to 800 100 400 to 600 Equal Replacement fluid. NS or D5 or RL Diabetic O.45 NS or neutralise D5 with 6IU Insulin, monitor RBS. 
Intervention  fluid regimen based on ERAS  Study Group Basic infusion is Maintenance DNS at 50 ml per hour In addition to the basic infusion, the urine production is replaced by 100% of its volume given as Balanced salt solution If the urine volume every hour for 3 to 5 hours is more than 250 mL and there is a good venous filling, the replacement volume to be reduced to 250 mL per hour. If the urine volume is less than 100 ml per hr and there are signs of insufficient venous filling, additional volume is given with BSS 250 to 500 ml If the urine volume is low and the patient has a good venous filling not believed to be dry then diuretics may be given.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Kidney transplant recipients between 18 to 65 years of age. 
 
ExclusionCriteria 
Details  1.Combined transplantation
2.Cadaveric kidney transplant
3.Age less than 18 years
4.Refused to give consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to normalization of creatinine in days  Baseline
day 1
day 3
day 7
day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Length of stay in hospital for donor & recipient. Length of stay in ICU for donor & recipient. Time to return of normal bowel movements. Time to return to ambulation.  Baseline
day 1
day 3
day 7
day 30 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   01/09/2025 
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 Yet Recruiting 
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  

Fluid therapy during Kidney Transplant is among the most challenging clinical tasks. Optimal fluid management has been shown to decrease delayed graft function after kidney transplant, which is associated with improved patient survival and long-term function, and decreased acute rejection. The choice between the use of vasopressors and fluids for hypotension is too simplistic in most cases. Implementing cardiac output monitoring could help guide adequate fluid resuscitation. The general approach to fluid resuscitation in patients undergoing major surgery based on current evidence should be as much as required, as little as possible. Traditionally, the perioperative volume infusion regimen in kidney transplant has been guided by central venous pressure as an estimation of the patient’s volume status and mean arterial pressure. However excessive volume infusion to the point of no further fluid responsiveness can damage the endothelial glycocalyx and is no longer considered to be the best approach. Achievement of adequate flow to maintain sufficient tissue perfusion without maximization of cardiac filling remains a challenge.ERAS adopts a multimodal, multidisciplinary approach to provide seamless perioperative care of the surgical patient. ERAS pathways should include a team consisting of surgeons, anesthesiologists, an ERAS coordinator, nursing and other staff from units that care for the surgical patient. The implementation of ERAS protocols has resulted in significant benefits to both the patients and hospitals with a shorter length of hospital stay by 30–50%, a similar rate of complication decrease, and a significantly reduced re-admissions rate to the hospital. An emerging component and a key element for the success of Enhanced Recovery After Surgery (ERAS) protocols has been the concept of goal-directed fluid therapy (GDT). GDT related to ERAS protocols attempts to minimize complications associated with fluid imbalance during surgery.

In our study, we hypothesize that our protocolised fluid therapy based on ERAS would be equivalent in time to normalization of creatinine in kidney transplant recipients, as compared to the standardized fluid therapy. 

 
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