| CTRI Number |
CTRI/2024/10/075105 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing how Plasmalyte and Normal saline affects electrolyte imbalance after kidney transplant surgery |
|
Scientific Title of Study
|
Comparison of the efficacy of Plasmalyte with Normal saline on the incidence of post-operative dyselectrolytemia among renal transplant recipients – a randomized controlled 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 |
Dr Sreejith Parameswaran |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. |
| Address |
Department of Nephrology, JIPMER - Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489148338 |
| Fax |
|
| Email |
sparameswaran@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedhara Gowri S |
| Designation |
Senior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. |
| Address |
Department of Nephrology, JIPMER - Puducherry
Dhanvanthri Nagar, Gorimedu, Puducherry 65006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7901894193 |
| Fax |
|
| Email |
kedha.sai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kedhara Gowri S |
| Designation |
Senior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. |
| Address |
Department of Nephrology, JIPMER - Puducherry
Dhanvanthri Nagar, Gorimedu, Puducherry 65006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7901894193 |
| Fax |
|
| Email |
kedha.sai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund, Jawaharlal Institute of Postgraduate Medical Education and Research,
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, India-605006 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [IT IS A CENTER INITIATED STUDY WITH INTRAMURAL FUNDING] |
|
|
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 Sreejith Parameswaran |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of nephrology, Super speciality block, 2nd floor, room number 308,
Dhanvanthri Nagar, Gorimedu, Puducherry 605006
Pondicherry
PONDICHERRY |
9489148338
sparameswaran@jipmer.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics committee Interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline and 5% dextrose |
Normal saline intraoperatively and Normal saline and 5% dextrose in 2:1 ratio post-operatively till 48 hours |
| Intervention |
Plasmalyte |
Plasmalyte intraoperatively and post-operatively till 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult male or female live renal allograft recipients and deceased donor renal allograft recipients undergoing transplant at our center |
|
| ExclusionCriteria |
| Details |
Multi-organ transplants |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative incidence of dyselectrolytemia among the renal transplant recipients |
at 48 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the quantity of potassium, magnesium, calcium and phosphorous supplementation between the patients treated with plasmalyte and normal saline |
during first 48 hours post transplantation |
| To compare the incidence of acidosis between the patients treated with plasmalyte and normal saline |
during first 48 hours post transplantation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomized, unblinded, parallel group active controlled trial comparing the efficacy of plasmalyte with normal saline and dextrose infusion on the post-operative incidence of dyselectrolytemia among the renal transplant recipients in the first 48 hours. The secondary outcomes are to compare the quantity of potassium, magnesium, calcium and phosphorous supplemented and to compare the incidence of acidosis during first 48 hours of transplantation |