| CTRI Number |
CTRI/2018/12/016693 [Registered on: 17/12/2018] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two different methods of fluid management on function of kidney in patients undergoing surgery for kidney stones |
|
Scientific Title of Study
|
Stroke volume variation directed versus conventional fluid therapy for postoperative acute kidney injury after percutaneous nephrolithotomy - a randomised pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and GTB Hospital, Dilshad Garden
Delhi
North East
DELHI
110095
India |
| Phone |
01122592415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aparna Mohan |
| Designation |
PG student |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and GTB Hospital, Dilshad Garden
Delhi
North East
DELHI
110095
India |
| Phone |
7289979633 |
| Fax |
|
| Email |
aparna.mohan0211@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Mohan |
| Designation |
PG student |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and GTB Hospital, Dilshad Garden
Delhi
North East
DELHI
110095
India |
| Phone |
7289979633 |
| Fax |
|
| Email |
aparna.mohan0211@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Dilshad Garden, Shahadra, Delhi 110095
|
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
Dilshad Garden, Shahadra
Delhi
110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Asha Tyagi |
University College of Medical Sciences and GTB Hospital |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and GTB Hospital,Dilshad Garden, Shahadra, Delhi 110095
North East
DELHI |
9818606404
drashatyagi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research (University College of Medical Sciences) |
Approved |
| Institutional Ethics Committee-Human Research, University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group S |
Stroke volume variation directed intaoperative fluid therapy |
| Comparator Agent |
group C |
conventional fluid therapy |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those patients who are scheduled for pcnl (percutaneous nephrolithotomy) surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
patients <16 years and >65 years
Those receiving renal replacement therapy or with transplanted kidney or clinical evidence of significant dysrhythmia, cardiac failure,stroke, coronary heart disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of early postoperative AKI as defined by the KDIGO criteria (i.e., serum creatinine with/without urine output) |
Preoperative, 24 hours and 48 hours postoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of AKI as defined by KDIGO criteria |
estimation of serum creatinine values preoperatively as well as 24 hours and 48 hours postoperatively
urine output will be considered if estimates of hourly collection are available |
| change in serum creatinine values |
difference between serum creatinine values preoperatively and postoperatively at 24 hours and 48 hours |
| change in estimated GFR which will be calculated using MDRD equation. |
difference between serum creatinine values preoperatively as well as 24 hours and 48 hours postoperatively. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/12/2018 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication from the study at present. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of present study is to evaluate postoperative acute kidney injury in patients undergoing PCNL surgery, following intraoperative use of conventional versus stroke volume variation directed fluid therapy.
The primary objective will be to evaluate incidence of early postoperative acute kidney injury as defined by the KDIGO criteria. The secondary objectives are to evaluate severity of acute kidney injury, change in serum creatinine and change in estimated GFR.
This will be a prospective, randomised,blinded pilot study which includes adult patients of age between 16 and 65 years scheduled for PCNL surgery under general anaesthesia.The study population will be divided in to 2 goups, 30 patients in each and intraoperative fluid administration carried out accordingly. For stroke volume variation directed fluid therapy, fluid boluses will be used whenever the variation is >10% in supine or >14% in prone position; in conventional group we will use the formula of Holiday and Segar for estimating fluid volumes.
We will be following up patients for incidence of early postoperative acute kidney injury upto 48 hours postoperatively as well as severity of acute kidney injury , changes in serum creatinine and eGFR.
Intergroup comparison for qualitive data will be done using chi-square or Fischer’s exact test, for non- normally distributed quantitative data using Mann-Whitney U test, and for normally distributed quantitative data using unpaired t-test. |