Renal stone culture for detecting Post PCNL infection

Recruiting

Conditions: Calculus of kidney, URINE CULTURE AND STONE CULTURE IN PATIENTS UNDERGOING PCNL.,

Registration Number: CTRI/2018/03/012765

Lead Sponsor: University College of Medical Sciences University of Delhi

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 Novâ€™ 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 72

Inclusion Criteria

Inclusion Criteria: 1.Adults Patients with indications For PCNL fit for surgery 2.
Patients with sterile preoperative midstream urine culture.

Exclusion Criteria

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.
Non consenters/unable to comply with protocol requirements.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Intra-operative Stone culture positivity, pelvic urine culture positivity, postoperative urine culture,(organisms cultured will be correlated in all the above cultures).	48 hours
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 Measures

Name	Time	Method
1. Presence of known risk factors (as per Annexure),	2. Clavein grade of complications (as per Annexure),

Trial Locations

Locations (1): University College of Medical Sciences University of Delhi & GTB Hospital
🇮🇳
East, DELHI, India
University College of Medical Sciences University of Delhi & GTB Hospital
🇮🇳East, DELHI, India
Prof Iqbal Singh
Principal investigator
11-22586262
iqbalsinghp@yahoo.co.uk