| CTRI Number |
CTRI/2023/11/060307 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the role of kidney stone culture in predicting and treating infections occurring after Percutaneous Nephrolithotripsy(PCNL) surgery for kidney stone. |
|
Scientific Title of Study
|
Correlation between stone culture and infective complications of PCNL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnakanth AVB |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104
Udupi KARNATAKA 576104 India |
| Phone |
9655181450 |
| Fax |
|
| Email |
krishnakanth002@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Padmaraj Hegde |
| Designation |
Head of Unit 2 - Department of Urology and Renal Transplant |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104
Udupi KARNATAKA 576104 India |
| Phone |
9900264579 |
| Fax |
|
| Email |
padmaraj.hegde@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Krishnakanth AVB |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104
Udupi KARNATAKA 576104 India |
| Phone |
9655181450 |
| Fax |
|
| Email |
krishnakanth002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104 |
| 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 |
| Dr Krishnakanth AVB |
Kasturba Medical College and Hospital |
Room no: 14, Department of Urology and Renal Transplant OPD, First floor, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104 Udupi KARNATAKA |
9655181450
krishnakanth002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing PCNL.
Patients treated for prior stone related uro-sepsis.
Presence of indwelling DJ stent/ catheter or PCN (Subset – To assess their microbial characteristics). |
|
| ExclusionCriteria |
| Details |
As it is only an observational study, no exclusion criteria is being applied. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between stone culture and infective complications of PCNL. |
Baseline, POD-0,POD-1 and at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between stone culture & renal function.
Correlation between stone culture & pre-operative urine culture in all patients included in the study.
Correlation between stone culture & blood culture in patients with uro-sepsis before or after PCNL.
Culture & sensitivity patterns in our population.
Correlation between stone culture & stone analysis.
Correlation between stone culture & staghorn calculi. |
Baseline, POD-0,POD-1 & at 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
05/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/12/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Urosepsis in post-operative period may prove to be catastrophic despite adequate pre-operative antibiotic coverage, and negative urine culture. Culture of the stone could thus be used as an early guide for treatment or prevention of post-operative urosepsis. Stone culture is not a usual practice in endourologic surgeries, and pre-operative urine cultures have been heavily relied on for treatment of post-operative infections and sepsis. The aim of this study was to find correlation between intra-operative stone culture obtained during PCNL with pre-operative urine culture and its correlation with infective complications related to the procedure. Primary Objective - To assess the correlation between stone culture and infective complications of PCNL. Justification for study : The high rates of post-PCNL infective complications warrant the need for well-defined predictive factors and high index of suspicion in the prediction of such complications. Stone culture will help in predicting infective complications in PCNL and help in administering appropriate intervention. Benefits of the study: In determining the role of stone culture in predicting infective complications of PCNL so as to administer timely intervention. To assess the stone culture sensitivity in local population so that any changes if required can be implemented in the current antibiotic protocol in our department. Ethical considerations: Institutional Ethics Committee clearance obtained. Consent forms will be obtained from the patient if they are willing to participate in the study. Confidentiality will be maintained as identities of participants will not be revealed and only their hospital ID numbers will be used for reference in the study. Study Hypothesis - There is positive correlation between stone culture and occurrence of postoperative infective complications of PCNL.
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