| CTRI Number |
CTRI/2018/01/011638 [Registered on: 31/01/2018] Trial Registered Prospectively |
| Last Modified On: |
12/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the outcomes of two intraoperative fluid management strategies to guide fluid therapy in renal transplant recepient patients |
|
Scientific Title of Study
|
Intra-operative fluid management in end stage renal disease patients undergoing renal transplantation: Comparison of Pulse Pressure Variation with Central Venous Pressure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowtham K |
| Designation |
Junoir Resident |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of anaesthesia and intensive care, Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8113857581 |
| Fax |
|
| Email |
kgdx08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamal Kajal |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of anaesthesia and intensive care, Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamal Kajal |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of anaesthesia and intensive care,Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560412726 |
| Fax |
|
| Email |
kamal.kajal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research(PGIMER), Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate institute of medical education and researchPGIMER Chandigarh |
| Address |
Postgraduate institute of medical education and research(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 |
| Dr Gowtham K |
Postgraduate institute of medical education and research, Chandigarh |
Department of Renal Transplant Surgery
Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH |
8113857581
kgdx08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate institute of medical education and research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Central venous pressure guided fluid management intraoperatively |
Central venous pressure as the basis for guiding fluid management comes from the belief that CVP reflects intravascular volume and hence used frequently in guiding fluid therapy intraoperatively |
| Intervention |
Pulse Pressure Variation Guided Fluid Management Intraoperatively |
Pulse Pressure Variation (PPV) is a dynamic index of fluid responsiveness based on the mechanical ventilation induced variation of stroke volume and stroke volume related variations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with End Stage Renal Disease undergoing Renal Transplantation |
|
| ExclusionCriteria |
| Details |
Active coronary artery disease or congestive heart failure
Atrial fibrillation or flutter
Valvular Heart Disease
Significant pulmonary insufficiency
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the ability of Pulse Pressure Variation guided fluid therapy as an alternative to CVP guided fluid therapy in renal transplant recipients by comparing the amount of fluid administered at the end of surgery |
1 hour post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare adequacy of tissue perfusion at the end of surgery.To find out the total volume of fluid administered in two groups during surgery and in the
immediate post-operative period
|
day 1 post surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/02/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized double blind controlled study to determine determine the ability of Pulse Pressure
Variation guided fluid therapy as an alternative to CVP guided fluid therapy in
renal transplant recipients by assessing the amount of fluid used in both groups and tissue perfusion by lactate levels in both the groups and urine output and dialysis requirement in both the groups |