| CTRI Number |
CTRI/2025/03/083107 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effectiveness of ultrasound in patients of early phase of renal transplant for fluid management. |
|
Scientific Title of Study
|
Compare efficacy of POCUS vs traditional methods in fluid management in early post transplant period |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Katyayani |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Nephrology,
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9459953653 |
| Fax |
|
| Email |
drkt4phcchobin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Divyaveer |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Nephrology,
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8017062986 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Katyayani |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Nephrology,
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09459953653 |
| Fax |
|
| Email |
drkt4phcchobin@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER Chandigarh, INDIA
160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER Chandigarh 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 Katyayani |
PGIMER Chandigarh |
Department of nephrology,
Nehru complex
Chandigarh
CHANDIGARH |
9459953653
drkt4phcchobin@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing live related renal transplantation |
|
| ExclusionCriteria |
| Details |
Unwilling to give consent
Patients with severe valvular lesions
Patients who are multiorgan recipient
Patients who is in overt sepsis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To quantify fluid status in immediate post transplant using traditional, pocus and bioimpedance.
To compare the efficacy of traditional versus pocus finding in diagnosis of fluid excess. |
Day 7 of immediate post transplant period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establish algorithm for fluid management in immediate post transplant period. |
With in one year from commencement of study. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| 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
|
Renal transplantation improves survival and quality of life , hence it is modality of choice for treating ESRD patients. “The kidneys receive approximately 25% of the body’s total cardiac output (CO) which is essential for maintaining the osmolarity of body fluids and for maintaining extracellular volume. Patients with renal failure often have electrolyte imbalances and they tend to oscillate in their volume status between hypovolemia and hypervolemia “.This results in a very narrow safety margin for intravenous fluid resuscitation and maintenance. Patients undergoing kidney transplantation are at risk of developing DGF, acute kidney injury (AKI) and fluid overload in the post operative period.†Fluid management during intraoperative and perioperative period affects hemodynamics and perfusion of the graft and may pose the risk of peri-operative cardiac events . Fluid therapy if given adequately decrease delayed graft function. |