| CTRI Number |
CTRI/2024/04/065709 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Recovery of Patients After Kidney Transplant: Following a special set of plan before, during and after surgery vs. Standard Care being followed in the hospital |
|
Scientific Title of Study
|
Enhanced recovery after surgery in patients undergoing renal transplantation in India: a prospective, randomised, control 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 |
Neha Pathania |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018484731 |
| Fax |
|
| Email |
dr.npathania15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Kajal |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kajal |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12, Pin Code 160012, India |
| 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 Neha Pathania |
Post Graduate Institute of Medical Education and Research |
Nehru hospital Renal Transplant operation theatre and Nehru hospital Extension Renal Transplant ICU of Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12, Pin Code 160012, India
Chandigarh
CHANDIGARH |
7018484731
dr.npathania15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS GROUP - Renal transplant recipients receiving perioperative care using ERAS protocol |
The recipients falling under this group will be delivered certain elements of the Enhanced Recovery after Surgery protocol across three phases including preoperative workup and perioperative and postoperative periods till the time of discharge from hospital and will be followed up till one month post surgery |
| Comparator Agent |
NON ERAS GROUP - Renal transplant recipients receiving routine standard of care |
The recipients falling under this group will be continued to be managed as per the standard of care being followed routinely in the institute till the time of discharge from hospital and will be followed up till one month post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All living donor renal transplant patients between the age of 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1. Refusal to give informed consent
2. Patients with contraindications to regional blocks
3. Patients undergoing additional transplant (dual kidney, pancreas, liver)
4. All deceased donor kidney transplant patients
5. Patients encountering intraoperative surgical complications |
|
|
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 |
| To compare postoperative length of stay in the renal transplant ICU between the ERAS and NON ERAS group of patients |
At 4 weeks of time from the day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional recovery of patients
Feasibility of adherence of protocol
Death or graft failure |
At 4 weeks of time from the day of surgery |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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="0"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Enhanced Recovery After Surgery (ERAS) programs consist of certain specific protocols which are designed to mitigate the perioperative stress, improve recovery of patient after surgery and decrease the length of hospital stay in surgical patients. The objective of this study will be to observe the impact of ERAS protocol constructed for our institute on renal transplant patients in terms of early functional recovery, length of stay in hospital post operatively and clinical outcomes over a period of one month. Comparison of various elements will be done in two groups, one following the ERAS protocol and the other following the routine standards of care in the institute |