Perioperative Prophylaxis for Percutaneous Nephrolithotomy: Randomized Study Concerning the Drug and Dosage

Abstract

Purpose:

To compare sulbactam-ampicillin and cefuroxime antibiotics for prophylaxis of percutaneous nephrolithotomy (PCNL) and to find out the optimal regimen for antibiotic maintenance to prevent systemic inflammatory response syndrome (SIRS).

Patients and Methods:

Between February 2010 and March 2011, a total of 198 patients in whom PCNL was performed were prospectively randomized into two main groups regarding the type of prophylactic antibiotic (group1: sulbactam-ampicillin, group 2: cefuroxime). Each group was further randomized according to duration of antibiotic maintenance (a: single dose prophylaxis, b: additional dose 12 hours after prophylaxis, c: beginning with prophylactic dose until the nephrostomy tube removal). Seven patients in whom purulent urine was obtained through the access needle were excluded from the study. Groups were compared in terms of stone- and operation-related factors as well as preoperative urine cultures, access cultures, stone cultures, postoperative urine cultures, and presence of SIRS.

Results:

A total of 191 patients (group 1: 95, group 2: 96) were evaluated. Mean patient age, body mass index, stone size, and perioperative outcomes were similar. Positive culture rates did not differ between groups. SIRS was observed in 13 (43.3%) patients in group 1 and 17 patients (56.7%) in group 2 (P=0.44). The relation between duration of antibiotic maintenance and SIRS development was not different in each group (P=0.95 for group 1, P: 0.39 for group 2). Urosepsis was observed in two patients, and one patient died because of septic shock.

Conclusions:

Sulbactam-ampicillin and cefuroxime antibiotics can be used safely for prophylaxis of PCNL. Single dose administration is sufficient.

Introduction

P ercutaneous nephrolithotomy (PCNL) is widely used in the surgical treatment of patients with kidney stones larger than 2 cm in diameter with success rates up to 90%.¹ Although PCNL is preferred because of its minimally invasive nature, minor and major complications are reported in up to 83% of cases.¹ Infectious complications are among the most common while bacteremia, fever, and endotoxemia rates reach to 23%, 25% and 34%, respectively.² Because of high infectious complication rates, antibiotic prophylaxis is highly recommended.

Urosepsis still develops, however, despite the fact that sterile urine is obtained before the procedure and antibiotic prophylaxis is performed. Septicemia after PCNL is seen in 0.3% to 2.5%.² O'Keeffe and associates³ reviewed retrospectively a series of 700 patients undergoing upper tract manipulation; septicemia developed in 9, and 66% of them died. Infectious complications may still develop in patients with preoperative sterile urine, and this is usually attributed to infection in the upper tract (either renal pelvic urine or stone) that cannot be demonstrated with bladder urine culture.

Antibiotic prophylaxis is performed before the surgery to prevent infectious complications and determined according to the antimicrobial resistance and possible complications. Both European Association of Urology (EAU) and American Urological Association (AUA) guidelines recommend antibiotic prophylaxis for PCNL.^4,5 Trimethoprim/sulfamethoxazole, second- or third-generation cephalosporins, aminoglycosides, aminopenicillins with beta-lactamase inhibitors, and quinolones are recommended antibiotics for prophylaxis; however, controversy still exists concerning duration and dose of prophylaxis.⁶

Systemic inflammatory response syndrome (SIRS) is the response of the body against infectious or noninfectious (trauma, burn, acute pancreatitis, etc.) stimulants⁷ and is widely used in clinical practice to demonstrate sepsis because of its high sensitivity.

This study is designed to determine if there is a difference between sulbactam/ampicillin and cefuroxime and what is the most favorable drug regimen in preventing infectious complications, and thus SIRS.

Patients and Methods

Study design

After obtaining Institutional Review Board approval, 198 patients undergoing PCNL from February 2010 to March 2011 who were eligible according to strict inclusion criteria were enrolled into the study. Patients with confounding factors (chronic renal failure, diabetes mellitus, life threatening condition [severe heart failure, new onset myocardial infarction or stroke, etc.], known penicillin/cephalosporin allergy, abnormal liver function test results, and hematologic disease [leukopenia, eosinophilia, thrombocytopenia], and patients aged less than years 18) that would predispose to SIRS were excluded from the study.

Patients were randomized into two groups according to the type of antibiotic used (group 1, sulbactam-ampicillin and group 2, cefuroxime). Group 1 was further randomized as group 1a (1.5 g sulbactam-ampicillin 30 minutes before surgery), group 1b (1.5 g sulbactam-ampicillin 30 minutes before and 12 hours after surgery), and group 1c (1.5 g sulbactam-ampicillin 30 minutes before surgery, and then 1 g sulbactam-ampicillin every 6 hours until removal of the nephrostomy tube). Group 2 was also randomized as group 2a (1.5 g cefuroxime 30 minutes before surgery), group 2b (1.5 g cefuroxime 30 minutes before and 12 hours after surgery), and group 2c (1.5 g cefuroxime 30 minutes before surgery, and then 750 mg intravenous cefuroxime every 8 hours until removal of the nephrostomy tube).

After randomization, seven patients were excluded from the study because of purulent urine from the access needle, and data of 191 patients were analyzed.

Patient assessment

Patient-related (age, sex, body mass index, history of open surgery and extracorporeal shockwave lithotripsy) and stone-related (size, localization, opacity) factors were recorded. The stone burden was determined based on radiographic studies as proposed by the EAU guidelines.⁸ The approximate stone surface area in cm² was calculated from the length and width of the stone on plain radiography of the kidneys, ureters, and bladder or on intravenous urography (IVU) for radiolucent stones. Stones were classified as simple (isolated pelvic or caliceal) or complex (stone in more than one caliceal system, partial or complete staghorn stones).

Preoperatively, complete blood cell count, serum creatinine measurement, platelet count, bleeding and coagulation profile, and urine cultures were performed in all patients. Patients with positive urine cultures were treated accordingly until sterile urine was obtained. Radiologic evaluation was also performed, including IVU, Ultrasonography, and noncontrast CT. Plain radiography were repeated on operation day.

PCNL

All procedures were performed under general anesthesia with the patient in the prone position. Before positioning of the patients, cystoscopy was performed, urine culture was obtained, and a ureteral catheter was positioned. Access to the collecting system was performed by the attending urologist under C-arm fluoroscopy. First urine from the access needle was also sent for culture. Patients with purulent urine from the collecting system were excluded from the study. Dilation of the tract was performed with balloon or Amplatz dilators. A 26F rigid nephroscope was used for visualization of the collecting system. Stones were fragmented with an ultrasonic lithotripter (Swiss Lithoclast Master, EMS).

The final status of the collecting system was controlled with perioperative antegrade nephrostography. A 14F nephrostomy tube was placed at the end of all procedures.

Postoperative follow-up

The amount of irrigation fluid used, fluoroscopy time, operative time, number of accesses, auxiliary procedures performed, peroperative pelvicaliceal system perforation, postoperative fever, transfusion performed, any postoperative complications were noted. Hospitalization time was calculated from operation to discharge from hospital.

Daily blood cell count and serum creatinine measurement were performed for all patients during the hospitalization period. Blood and urine cultures were obtained when fever exceeded 38.5°C. Hemoglobin (Hb) change was calculated as (postoperative Hb–preoperative Hb)+(1/per transfused unit of blood).

Presence of SIRS criteria (body temperature >38°C or <36°C, heart rate >90/min, respiratory rate >20/min, white blood cell count >12,000UI or <4000UI) was monitored for all patients, and the presence of two or more criteria was accepted as SIRS. Treatment of patients with positive SIRS criteria and clinical suspicion of urosepsis was changed accordingly. Oral antibiotics were not prescribed on discharge.

Final stone status was determined with IVU or noncontrast CT at the end of 1 month, and success was defined as clearance of all stones.

Statistical analysis

Data were analyzed using Statistical Package for Social Sciences version 16 (SPSS Inc, Chicago, IL). Continuous variables were compared with the Mann Whitney U test. Proportions of categorical variables were analyzed for statistical significance using the chi-square test or the Fisher exact test. Binary logistic regression analysis was performed for multivariable analysis.

Results

Mean patient age was 42.8±13.7 (range 18–72) and 44.8±14.9 (range 20–75) years and mean stone size was 8.2±6.7 (range 1–35) and 8.8±8.3 (range 1.5–40) cm² for group 1 and group 2, respectively. Patient- and stone-related parameters of the two groups were similar (Table 1). Mean operative time was 74±31.1 (range 30–180) and 71.2±30.1 (range 30–140) minutes for group 1 and group 2, respectively (P=0.43). Mean hospitalization time was also similar between two groups (2.8±1.6 and 2.6±1.6 days, P=0.27). Operative findings and postoperative noninfectious complications are given in detail in Table 2. Urosepsis was observed in two patients each from different antibiotic groups, and one patient died because of septic shock from the sulbactam-ampicillin group.

Table 1.

Comparıson of Patıent- and Stone-Related Parameters

Parameters	Group 1 (sulbactam-ampicillin, n:95) Mean±SD	Group 2 (cefuroxime, n:96) Mean±SD	P value
Patient age (years)	42.8±13.7 (range 18–72)	44.8±14.9 (range 20–75)	0.35
Body mass index (kg/m²)	27±4.5	26.8±4.2	0.71
Stone size (cm²)	8.2±6.7 (range 1–35)	8.8±8.3 (range 1.5–40)	0.95
	% (n)	% (n)
Sex
Male	54.7% (52)	56.2% (54)	0.83
Female	45.3% (43)	43.8% (42)
History of open surgery	17.9% (17)	22.9% (22)	0.39
History of SWL	26.3% (25)	31.2% (30)	0.45
Presence of solitary kidney	1.1% (1)	4.2% (4)	0.17
Degree of hydronephrosis
Grade 1/grade 2	45.3% (43)	49% (47)	0.61
Grade 3/grade 4	54.7% (52)	51% (49)
Stone type
Simple	69.5% (66)	59.4% (57)	0.14
Complex	30.5% (29)	40.6% (39)
Opacity of stone
Opaque	92.6% (88)	85.4% (82)	0.19
Nonopaque	4.2% (4)	5.2% (5)
Semiopaque	3.2% (3)	9.4% (9)

SD=standard deviation; SWL=shockwave lithotripsy.

Table 2.

Operative Findings and Postoperative Noninfectious Complications

Parameters	Group 1 (sulbactam-ampicillin, n:95) Mean±SD	Group 2 (cefuroxime, n:96) Mean±SD	P value
Amount of irrigation fluid (L)	20.3±19.2 (range 3–120)	19.6±13 (range 6–42)	0.75
Fluoroscopy time (min)	7.9±3.8 (range 2–20)	7.2±4.8 (range 1.1–20)	0.3
Operative time (min)	74±31.1 (range 30–180)	71.2±30.1 (range 30–140)	0.43
Nephrostomy removal time (days)	2.5±1.3 (range 1–5)	2.3±1.1 (range 1–10)	0.39
Hospitalization time (days)	2.8±1.6 (range 1–10)	2.6±1.6 (range 1–10)	0.27
	% (n)	% (n)
Lithotriptor
Pneumatic	7.4% (7)	7.3% (7)	0.95
Ultrasonic	84.2% (80)	86.5% (83)
Combined	3.2% (3)	2.1% (2)
None	5.3% (5)	4.2% (4)
Presence of intercostal access	9.5% (9)	7.3% (7)	0.58
Access number
1	14.7% (14)	13.5% (13)	0.81
>1	85.3% (81)	86.5% (83)
Presence of auxiliary procedures	4.2% (4)	5.2% (5)	0.74
Presence of pelvic perforation	4.2% (4)	3.1% (3)	0.69
Stone free	86.3% (82)	83.3% (80)	0.71
Need for blood transfusion	10.5% (10)	9.4% (9)	0.79

SD=standard deviation.

Antibiotic treatment because of positive urine culture 1 week before the procedure was given to 5.3% and 10.4% of patients, in groups 1 and 2, respectively (P=0.18). Although the postoperative SIRS rate increased in these patients, the difference was not significant (P=0.051). Bladder, renal pelvic urine, and stone culture positivity rates were also similar. Detailed culture positivity rates are given in detail in Table 3. Escherichia coli was the most commonly isolated bacteria from preoperative urine cultures while Pseudomonas aeruginosa was mostly isolated from stone cultures (Table 4).

Table 3.

Comparison of Culture Positivity Rates

Parameters	Group 1 (sulbactam-ampicillin, n:95)	Group 2 (cefuroxime, n:96)	P value
Preoperative voided urine culture positivity	5.3% (5)	10.4% (10)	0.18
Perioperative bladder urine culture positivity	5.3% (5)	2.1% (2)	0.24
Pelvic urine culture positivity	2.1% (2)	4.2% (4)	0.41
Stone culture positivity	13.7% (13)	8.3% (8)	0.24
Postoperative voided urine culture positivity	6.3% (6)	7.3% (7)	0.78

Table 4.

Pathogens Isolated from Varıous Cultures

Pathogens (n)	Preoperative voided urine culture	Perioperative bladder urine culture	Pelvic urine culture	Stone culture	Postoperative voided urine culture
CoNS		1		4
E coli	8	4	2	3	4
K pneumoniae	1	1	1	1	2
P aeruginosa	4		3	10	2
P mirabilis		1		1
ESBL(+) E coli	2				3
ESBL(+) K pneumoniae					1
Acinetobacter				2
>1 pathogens					1

CoNS=Coagulase-negative staphylococci; E coli=Escherichia coli; K pneumoniae=Klebsiella pneumoniae; ESBL=extended-spectrum beta-lactamase; P aeruginosa=Pseudomonas aeruginosa; P mirabilis=Proteus mirabilis.

SIRS criteria were seen in 30 (15.7%) patients. Of these 30 patients, 13 (43.3%) were from group 1 and 17 (56.7%) was from group 2. Detailed distributions of patients are given on Table 5. All groups and subgroups were similar by means of SIRS development rates.

Table 5.

Systemic Inflammatory Response Syndrome Development Rates in Antibiotic Groups and Dosage Subgroups

Presence of SIRS	Group 1 (ampicillin/sulbactam, n:95)			Group 2 (cefuroxime, n:96)			P value
(+)	13.7% (n:13)			17.7% (n:17)			0.44
	Group 1a (n:31)	Group 1b (n:33)	Group 1c (n:31)	Group 2a (n:32)	Group 2b (n:32)	Group 2c (n:32)
(+)	12.9% (n:4)	15.2% (n:5)	12.9% (n:4)				0.95
(+)				15.6% (n:5)	25% (n:8)	12.5% (n:4)	0.39

SIRS=systemic inflammatory response syndrome.

Discussion

PCNL is accepted as a clean contaminated wound, and antibiotic prophylaxis is recommended by urology guidelines, but the duration of prophylaxis is not well documented.^4,5 Urinary tract infection after PCNL, especially when postoperative sepsis develops, may result in a dangerous and life-threatening situation. Urinary sepsis has a low reported incidence but high (66%–80%) mortality rate.³ Serious systemic infections from bacterial contamination and release of endotoxins still develop even though all preventive measures are performed before and during the procedure. To our knowledge, this is the first randomized study designed to define the appropriate prophylaxis regimen for PCNL.

To demonstrate the inflammatory process objectively and consistently, we used SIRS criteria. Specificity of SIRS criteria is low because heart and respiratory rate is affected also by noninfectious causes. Although septic shock is a more precise measure, because it is seen rarely with present preventive techniques, significant results would be precluded with moderate sample sizes. Bag and colleagues⁹ used only fever and increased leukocyte number to increase specificity, but we used all four criteria so as to not decrease the sensitivity.

Urine culture 1 week before operation and appropriate treatment in patients with positive results would be sufficient to provide sterile urine during the operation.¹⁰ We obtained urine culture from all patients 1 week before the procedure. In this study, 15 (7.8%) patients with positive urine culture were treated before the operation. Although the postoperative SIRS rate increased in these patients, the difference was not significant (P=0.051). Similarly, Chen and associates¹¹ and Draga and coworkers¹² did not reveal a significant relation between preoperative urine culture and postoperative SIRS. Mariappan and associates¹³ proposed an extended period of antibiotic prophylaxis before surgery because they argue midstream urine culture does not represent the infection in the upper tract, especially with an obstructed system and larger stones. We did not prolonged antibiotic prophylaxis before the surgery, however.

Charton and colleagues,¹⁴ in 1986, demonstrated the benefit of prophylactic antibiotics in PCNL in reducing infectious complications and showed post-PCNL bacteriuria and fever rates reached up to 35% and 10%, respectively, in patients with sterile urine cultures. Darenkov and coworkers¹⁵ also showed that intravenous and oral ciprofloxacin prophylaxis reduced postoperative infection rate from 40% to 0% and 17%, respectively.

EAU guidelines recommend cephalosporins (second or third generation), co-trimoxazole, fluoroquinolones, or aminopenicillin/beta lactamase inhibitor combination for prophylaxis without any preference.⁴ There is no information, however, regarding dosage and duration of prophylaxis.⁴ On the other hand, the AUA guidelines mention short-term prophylaxis according to a prospective, nonrandomized trial.⁵ Dogan and associates¹⁶ compared single dose vs short-term ofloxacin prophylaxis in their 81 patient series and did not reveal significant difference in bacteriuria, bacteremia, urine culture positivity, and postoperative fever rates between two groups.

The only randomized controlled trial that compared antibiotic prophylaxis (single dose, 1g, intravenous cefotaxime) with placebo was performed by Fourcade and colleagues.¹⁷ The study group was too small; thus, a significant difference was not noticed. Bag and coworkers⁹ showed that long-term nitrofurantoin (starting 1week before surgery) prophylaxis in addition to standard cephalosporin prophylaxis significantly reduces endotoxemia and urosepsis risk. Nitrofurantoin prophylaxis reduced culture positivity, endotoxemia, and SIRS development by 64%, 88%, and 69%, respectively. Mariappan and colleagues¹³ also showed that 1 week of twicedaily 250 mg oral ciprofloxacin prophylaxis in addition to single-dose gentamicin prophylaxis significantly reduces upper urinary tract infection and urosepsis risk, especially in patients with stones larger than 20 mm in greatest diameter or with dilated a collecting system.

We used either ampicillin-sulbactam or cefuroxime for single-dose, short-term, and long-term prophylaxis according to EAU guidelines. Our results, on the other hand, showed no difference between both antibiotic groups or between different prophylaxis durations.

Although the definition of septic shock differs in various studies, reported rates vary between 1% and 2%.¹ In this study, septic shock developed in one (0.5%) patient. E coli and P aeruginosa were isolated from blood cultures, and the patient died because of multiple organ insufficiency. In centers in which Pseudomonas is highly isolated from urine or stone cultures, prophylaxis should also cover Pseudomonas. Otherwise, this should be avoided to prevent development of highly resistant strains.

Large stones are composed of phosphate in most cases and usually host infectious agents. Shigeta and associates¹⁸ showed that stone culture is positive in 10% of cases, and this rate increases with increasing stone size. In our study, stone cultures were positive in 10.9% of patients. Mariappan and colleagues¹³ also reported increased culture positivity in stones larger than 20 mm. We did not notice any association between stone size and stone culture positivity and also SIRS development risk, however, so it is not necessary to change or modify antibiotic prophylaxis regimen in patients with larger stones.

A dilated collecting system and hydronephrosis generally occur with large, obstructing stones, and bladder urine generally does not correlate with upper system urine culture. Kumar and coworkers¹⁹ showed that hydronephrosis is an independent risk factor in the development of SIRS. We compared grade 0 and 1 hydronephrosis with grade 2 and 3 hydronephrosis but did not notice any difference between the two groups. Female sex was also a risk factor for renal pelvic urine and stone culture positivity in the study of Kumar and coworkers.¹⁹ Bacteriuria, urinary tract infections, and urosepsis are twice as common in women, and low perineal hygiene, atrophic vaginitis, and cystocele may be attributed to this difference.²⁰ Our results, however, did not show any sex difference. We therefore do not recommend different antibiotic regimen for patients with high-grade hydronephrosis or female sex.

Increased operative time and thus increased amount of irrigation fluid may increase postoperative fever risk. Dogan and colleagues¹⁶ accepted 102 minutes and 23 liters as critical values and showed that postoperative fever risk increases above these values. Our results did not reveal any relation between operative time and development of SIRS in different prophylaxis groups.

Current studies show a relation between SIRS and stone culture positivity. Korets and coworkers²¹ found that renal pelvic urine and stone culture have the highest concordance with development of SIRS. They recommend collecting pelvic urine and stone cultures to identify the offending organism in patients at risk for sepsis. Gonen and associates²² also demonstrated increased postoperative fever in patients with positive stone culture in their study. It is difficult to show infection in a system obstructed with a stone by using bladder urine culture. Mariappan and colleagues¹³ revealed stone culture and renal pelvic urine as important factors in predicting postoperative sepsis. Our results, however, showed that bladder urine culture is the only culture that correlates with SIRS (P=0.02; conficence interval [CI]: 8.1 [1.71–38.3]). A significant relation was not seen between renal pelvic urine and stone culture and SIRS development. This may be explained with the low number of cases with severe hydronephrosis and possible contamination during collection of bladder urine. It is possible to predict the status of the upper system more accurately with bladder urine in nonobstructed systems.

Transfusion seems to be another positive predictive factor for development of SIRS (P=0.0001; CI: 8.44 [3.06–23.28]). Chen and colleagues¹¹ also showed that SIRS develops more commonly in patients receiving blood transfusion. It is possible to assume that traumatized caliceal necks and protective mucosa make the development of bacteremia and endotoxemia easier. This may explain why SIRS develops more commonly in transfused patients. Chen and colleagues¹¹ showed that a second access to remove a 20 mm stone increased the risk of SIRS from 62% to 97.5% and should be performed as a second operation especially if the first access caused severe bleeding.

Intercostal access seems the most important factor in increasing SIRS risk. We performed intercostal access in 16 (8.3%) of 191 patients, and SIRS developed in 8 (50%) of them. Fever, however, was seen in only one of eight patients, and the remaining seven patients had leukocytosis and increased respiratory rate. Increased respiratory rate may be attributed to pleural irritation. As a result, we think that intercostal access increases the risk of SIRS but not postoperative infection.

Although the sample size in our study is small, we think that the study is designed well enough to compare efficiencies of different antibiotic groups and regimens. Another limitation of our study is lack of stone analysis results for all patients. Although staghorn stone rates are high in both groups, it is not possible to assume these are struvite stones because Proteus was not isolated in most of stone cultures. There are some other infection markers such as procalcitonin, C-reactive protein, and absolute neutrophil count that can be used to demonstrate infection; however, in this study we used classic SIRS and SIRS criteria.

Conclusion

Antibiotic prophylaxis for PCNL is highly recommended. Cefuroxime and sulbactam-ampicillin seem to have similar efficiency, and single-dose antibiotic prophylaxis will be enough to prevent infectious complications.

Footnotes

Disclosure Statement

No competing financial interests exist.

Abbreviations Used

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