| CTRI Number |
CTRI/2019/01/016847 [Registered on: 02/01/2019] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
correlating operative factors with outcome in renal transplant patients |
|
Scientific Title of Study
|
Correlation of perioperative factors with immediate graft function in renal transplant patients - A prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Heena Garg |
| Designation |
Senior Resident |
| Affiliation |
NIMS |
| Address |
Department of Anaesthesiology and Intensive care,
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
9464533877 |
| Fax |
|
| Email |
gargheena11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Heena Garg |
| Designation |
Senior Resident |
| Affiliation |
NIMS |
| Address |
Department of Anaesthesiology and Intensive care,
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
9464533877 |
| Fax |
|
| Email |
gargheena11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heena Garg |
| Designation |
Senior Resident |
| Affiliation |
NIMS |
| Address |
Department of Anaesthesiology and Intensive care,
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
9464533877 |
| Fax |
|
| Email |
gargheena11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMS |
| Address |
Department of anaesthesiology and intensive care,
Nizams institute of medical sciences, Panjagutta, Hyderabad, Telangana |
| 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 |
| Heena Garg |
NIMS |
Department of Anaesthesiology and Intensive care,
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
Hyderabad
TELANGANA |
9464533877
gargheena11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with end stage renal disease posted for kidney transplant |
|
| ExclusionCriteria |
| Details |
age less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of the perioperative factors on the immediate postoperative outcome of renal transplant. |
postoperative day 1 to day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/01/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Renal transplants are performed in patients with end stage renal disease (ESRD). It improves the quality of life and is a better alternative to dialysis in patients having chronic kidney disease (CKD). Both live as well as cadaver transplants are performed routinely in our institute. The number of successful transplants have increased dramatically in the last decade due to advancements in anaesthesia, surgical technique, inclusion of extended donor criteria and immunosuppression. An increase in cadaver transplant has been noted due to the increase in the practice of organ donation.The outcome of a transplant depends on many factors. In a live transplant, both donor and recipient factors come into play. Various studies have been done which have aimed to correlate the pre-operative and intraoperative factors with the graft function. While many studies are available to assess the long term outcomes of the transplant, few studies have demonstrated the effect of various perioperative factors on the immediate graft function (IGF) after the transplant. IGF has been defined as the formation of intraoperative urine with massive diuresis associated with a decrease in the serum creatinine and blood urea nitrogen (BUN). Patients are said to have a delayed graft function (DGF) if they require a dialysis within first week of transplant.The previous studies have not identified the various perioperative factors which are affecting the immediate outcome of the transplant the most. In our study, we aim to correlate the various perioperative factors to the immediate outcome of renal transplant and identify the modifiable and non-modifiable factors affecting the IGF. |