| CTRI Number |
CTRI/2019/01/017153 [Registered on: 18/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on cardiac function affecting renal blood supply in transplanted kidney |
|
Scientific Title of Study
|
Prospective Observational Study Of Perioperative Cardio-Renal Interactions In Transplanted Kidneys |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinivasan M |
| Designation |
Junior Resident |
| Affiliation |
Dept of Anaesthesia and Intensive care,PGIMER,chandigarh |
| Address |
Office of Depatment of Anaesthesia and Intensive care,4th Floor,Nehru Hospital,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9500475447 |
| Fax |
|
| Email |
srinivasan.m.2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KAMAL KAJAL |
| Designation |
Assistant Professor |
| Affiliation |
Dept of Anaesthesia and Intensive care,PGIMER,Chandigarh |
| Address |
Office of Depatment of Anaesthesia and Intensive care,4th Floor,Nehru Hospital,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinivasan M |
| Designation |
Junior Resident |
| Affiliation |
Dept of Anaesthesia and Intensive care,PGIMER,chandigarh |
| Address |
Office of Depatment of Anaesthesia and Intensive care,4th Floor,Nehru Hospital,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9500475447 |
| Fax |
|
| Email |
srinivasan.m.2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Medical Education And Research,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intesnsive carePGIMER |
| Address |
Office of Department of Anaesthesia and Intensive care,PGIMER,chandigarh |
| 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 |
| SRINIVASAN M |
Postgraduate Institute Of Medical Education And Research |
Department of Renal Transplant Surgery,PGIMER,Chandigarh
Chandigarh
CHANDIGARH |
9500475447
srinivasan.m.2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18-60 years, scheduled for renal transplant surgery |
|
| ExclusionCriteria |
| Details |
Atrial fibrillation/Atrial flutter/Severe Valvular Heart Disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the relationship of Renal Doppler indices with echocardiographic indices of left ventricular systolic and diastolic function in patients undergoing renal transplantation. |
Post Declamping Stage of renal transplant surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic dependence of Renal Resistive Index |
Post Transplantation |
|
|
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 1 |
|
Date of First Enrollment (India)
|
19/01/2019 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Renal Transplant is considered treatment of choice for patients with End Stage Renal Disease.Innovations in surgical, anaesthetic techniques and immunosuppressive agents have led to the surge in the number of transplants worldwide. In renal transplantation, the emphasis remains on favourable operative conditions, preservation of graft function and to reduce the incidence of Delayed Graft Function. Cardiovascular system and kidney function are tightly coupled. This cardio-renal interaction occurs primarily via hemodynamic factors but also via endogenous humoral factors that are associated with acute or chronic damage of the kidney and/or heart.In renal transplant surgery, one of the major determinant of graft outcome is good perfusion of the transplanted kidney. There is strong dependency of graft perfusion with vascular compliance and systemic hemodynamics.so we planed to investigate the relationship of Renal Doppler indices with echocardiographic indices of left ventricular systolic and diastolic function in patients undergoing renal transplantation. |