| 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
|
|
|
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
|
|
|
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. |