| CTRI Number |
CTRI/2022/03/040840 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ON KIDNEY FUNCTION AND FACTORS POINTING AT ACUTE KIDNEY INJURY AFTER KIDNEY STONE REMOVAL SURGERY |
|
Scientific Title of Study
|
A Prospective Observational Study On Renal Function And Factors Predicting AKI After Percutaneous Nephrolithotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Goli Venkata Sai Abhishek |
| Designation |
Registrar |
| Affiliation |
Kasturba Hospital |
| Address |
Room no 14
urology opd
kasturba hospital
manipal
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7674965678 |
| Fax |
|
| Email |
abhishekgoli897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chawla |
| Designation |
Prof & HOD |
| Affiliation |
Kasturba Hospital |
| Address |
Room no 14
urology opd
kasturba hospital
manipal
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmaraj Hegde |
| Designation |
Prof & HOU |
| Affiliation |
Kasturba Hospital |
| Address |
Room no 14
urology opd
kasturba hospital
manipal
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900264579 |
| Fax |
|
| Email |
padmaraj.hegde@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
Manipal
Udupi Dist
Karnataka
India
576104 |
|
|
Primary Sponsor
|
| Name |
KMC MANIPAL |
| Address |
KMC Hospital
manipal
udupi dist
karnataka |
| Type of Sponsor |
Private 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 |
| Goli Venkata Sai Abhishek |
Kasturba hospital |
Department of urology
Room No 14
Opd Block
Kasturba hospital
manipal
Udupi Dist
Karnataka
Udupi
KARNATAKA |
7674965678
abhishekgoli897@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing PCNL procedure >18years |
|
| ExclusionCriteria |
| Details |
Pregnant women
Bleeding diathesis
Ureteral calculi |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To analyse the incidence of post-PNL AKI
2. To analyse potential risk factors and outcomes |
The Incidence And The Risk Factors Can Only Be Analysed At The End Of The Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To analyse renal function in patients with nephrolithiasis |
This Is Done At The Begning Of The Study On The 1 st Day Of Admission |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
07/03/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be conducted on diagnosed patients of renal calculus disease getting admitted to Kasturba Medical College, Manipal.  Patients will be selected for study according to all inclusion and exclusion criteria.  Each patients renal status on admission will be recorded whether Normal,AKI,CKD,AKI ON CKD, and 3 moths prior status of renal functions.  The purpose of the study will be explained to the patient and informed consent will be obtained for collection of data in patient’s own vernacular language.  PNL protocols will be followed for evaluation, treatment and follow-up.  Demographic data like age, gender, body mass index (BMI), comorbidities including hypertension, diabetes mellitus, drug history of angiotensin converting enzyme inhibitors (ACE inhibitor), angiotensin II receptor blockers and beta blockers,NSAID’s.  Laboratory data include serial serum creatinine pre- and postoperation (12, 24, 48 h), hemoglobin (Hb), total leucocyte count (TLC),neutrophil lymphocyte ratio (NL ratio ),platelet lymphocyte ratio (PL ratio) Prothrombin time (PT), serum uric acid and urine culture.  Stone factors assessed by noncontrast computerized tomography of kidneys, ureter and bladder (NCCT KUB) and includes stone burden in cubic millimeters (volume = LxWxD), location and Hounsfield values and laterality.  The intraoperative factors includes puncture site, tract size, tract number, operative time, the need for blood transfusion, stone clearance, usage of ureteral stent or nephrostomy tube and intra op hypotension any ancillary procedures.  Postoperative complications were documented using the modified Clavien–Dindo grading system. Patients will be followed up after one month with USG KUB/ X-ray KUB.  Patients with postoperative AKI were followed up with serial creatinine values up to 3 months. |