| CTRI Number |
CTRI/2018/03/012765 [Registered on: 22/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective non-randomised observational analytical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Renal stone culture for detecting Post PCNL infection |
|
Scientific Title of Study
|
Efficacy of intraoperative renal stone culture in predicting Post PCNL Urosepsis-A Prospective observational analytical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Iqbal Singh |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences University of Delhi |
| Address |
Dept of Surgery(Urology)
University College of Medical Sciences University of Delhi
Shahadara
Dilshad Garden
Delhii-95
North East
DELHI
110095
India |
| Phone |
22586262 |
| Fax |
91-11-22590495 |
| Email |
iqbalsinghp@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani |
| Designation |
Post Graduate resident in surgery |
| Affiliation |
UCMS & GTB Hospital |
| Address |
Dept of Surgery
University College of Medical Sciences University of Delhi
Shahadara
Dilshad Garden
Delhii-95
North East
DELHI
110095
India |
| Phone |
9716257970 |
| Fax |
91-11-22590495 |
| Email |
shivanimc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani |
| Designation |
Post graduate resident in surgery |
| Affiliation |
UCMS & GTB Hospital |
| Address |
Dept of Surgery
University College of Medical Sciences University of Delhi
Shahadara
Dilshad Garden
Delhii-95
North East
DELHI
110095
India |
| Phone |
9716257970 |
| Fax |
91-11-22590495 |
| Email |
shivanimc@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences University of Delhi, Shahadara, Dilshad Garden, Delhi-95. |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences University of Delhi |
| Address |
Shahadara
Dilshad Garden
Delhi-95 |
| 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 |
| Prof Iqbal Singh |
University College of Medical Sciences University of Delhi & GTB Hospital |
Dept of Surgery (Urology) UCMS
North East
DELHI |
91-11-22586262
91-11-22590495
iqbalsinghp@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research University College of Medical Sciences University of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, URINE CULTURE AND STONE CULTURE IN PATIENTS UNDERGOING PCNL., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Adults Patients with indications For PCNL fit for surgery
2. Patients with sterile preoperative midstream urine culture
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre-op stents/PCN in situ/indwelling catheter
2. Positive preoperative urine culture /UTI/pyonephrosis
3. Contraindications of PCNL (uncorrected coagulopathy,pregnancy,unsafe access,pulmonary and cardiac disease,morbid obesity)Immunocompromised patients
4. Presence of concomitant /contralateral ureteric/ bladder stone
5. Patients on concomitant therapeutic antibiotics.
6. Non consenters/unable to comply with protocol requirements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intra-operative Stone culture positivity, pelvic urine culture positivity, postoperative urine culture,(organisms cultured will be correlated in all the above cultures).
2. For detecting SIRS features; Haemogram (leukocyte count), kidney function test, serum electrolytes, blood culture and USG abdomen in case of sepsis at 48hrs
|
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Presence of known risk factors (as per Annexure),
2. Clavein grade of complications (as per Annexure),
3. Antibiogram report, Hospital stay, Time to return to work(as per annexure).
|
Till time of discharge |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/11/2016 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title: EFFICACY OF INTRAOPERATIVE RENAL STONE CULTURE IN PREDICITNG POST PCNL UROSEPSIS Background: There is paucity in the published English literature on the efficacy of intraoperative renal stone culture in predicting post PCNL (Percutaneous cystolithotomy) urosepsis. In this study we have evaluated the efficacy of stone culture and pelvic urine culture and postoperative urine culture for detecting and predicting the occurence of (SIRS~Systemic Inflammatory Response Syndrome) in post operative patients undergoing standard PCNL. This to the best of our knowledge is not well documented in the published English/Indian literature. Aim: To evaluate the efficacy of intraoperative renal stone culture in predicting and detecting the occurence of post pcnl urosepsis/SIRS and to evaluate the proportion of patients with positive stone culture/pelvic urine developing post pcnl urosepsis . Design, setting and participants: This is prospective non randomized observational analytical study which included patients of nephrolithiasis undergoing PCNL as per protocol between Nov’ 2016 and April 2018 in our Institution. The patients were enrolled in to thus study as per protocol after approval by local ethics Committee and after administering a written informed consent. Interventions: Intraoperative stone culture,pelvic urine culture and postoperative urine culture was sent for detecting post PCNL urosepsis. Samples of blood for haemogram(leukocyte count),kidney function test,serum electrolytes,blood culture and USG abdomen were sent and done to detect any evidence of urosepsis at 48 hrs and or at time till discharge as per protocol. Outcome measures:Patients were evaluated for stone culture positivity,pelvic urine positivity and postoperative urine culture and organisms and all cultures were correlated. For detecting SIRS features,haemogram (leukocyte count),kidney function test,serum electrolytes,blood culture and USG abdomen in case of sepsis at 48hrs was also done. Secondarily presence of known risk factors diabetes, chronic renal failure, previous ipsilateral renal surgery, HIV ,coagulopathy, surgery complications and antibiogram report, hospital stay, time to return to work were observed and analysed separately as applicable. Results: AWAITED Conclusions: AWAITED |