Clinical trial NCT06210425: Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?
Official title: Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Calculi
Urinary Tract Infections
Sepsis
Keywords: Percutaneous nephrolithotomy
Urine culture
Antibiotics
Infectious complication
Sepsis
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients underwent midstream urine culture and drug sensitivity testing in the outpatient clinic. Upon admission, urologists selected sensitive antibiotics for anti-infective treatment based on the preoperative urine culture drug sensitivity test results. The treatment duration was 7 days, and urine cultures were re-examined on the 3rd and 7th days of sensitive antibiotic use. After 7 days of treatment with sensitive antibiotics, patients underwent mini-PCNL. Based on the urine culture results from the 3rd and 7th days, we analyzed the correlation between these results and infectious complications related to mini-PCNL.

Brief summary: Objective To explore the predictive value of urine culture re-examination in identifying infectious complications associated with mini-PCNL in patients with preoperative positive urine culture who were treated with sensitive antibiotics. Methods Prospective and consecutive clinical data were collected from patients whose preoperative urine culture was positive and who underwent PCNL at the Department of Urology, the First Affiliated Hospital of Guangzhou Medical University. If patients'preoperative urine cultures were positive, they would be treated with appropriate antibiotics in accordance with the culture-antibiogram test results, and urine cultures were repeated on day 3 and day 7. Patients would undergo mini-PCNL after the treatment of sensitive antibiotics for 7 days, and the correlation between the results of urine culture on day 3 and day 7 and infectious complications related to mini-PCNL after surgery was analyzed.

Detailed description: PCNL (Percutaneous Nephrolithotomy) is the preferred treatment option for kidney stones with a diameter of ≥ 2 cm . Hemorrhage and infection are the primary complications following PCNL. Thanks to the advancements in interventional techniques, most hemorrhagic complications can be controlled with interventional treatment. In contrast, related infectious complications, such as urosepsis, are more perilous and challenging to control. Therefore, measures should be taken to prevent the occurrence of post-PCNL infectious complications, among which the most critical is the use of perioperative antibiotics. Currently, there is no consensus in the academic community regarding the strategy for the use of perioperative antibiotics in patients with positive preoperative urine cultures undergoing PCNL , and there is controversy over whether it is necessary to recheck urine culture after treatment with sensitive antibiotics . Some scholars believe that urine culture should be rechecked after antibiotic treatment and surgery should be performed only after the culture turns negative , but others argue that it is unnecessary to recheck urine culture after antibiotic treatment . Generally, since antibiotics might induce false-negative results in urine bacteria, it is recommended to discontinue antibiotics for more than 3 days before re-examining the urine culture . However, urological patients often have stone obstruction combined with urinary tract infection, and discontinuing antibiotics might lead to the recurrence of the infection. Therefore, this article mainly explores the role of re-examined urine culture after treatment with sensitive antibiotics in predicting infectious complications related to mini-PCNL post-surgery.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Renal stone diameter ≥ 2 cm, complex renal stones, or failed ESWL treatment.
3. Consent to undergo PCNL with a positive midstream urine culture preoperatively.
4. ASA score of I or II.

Exclusion Criteria:

1. Coexisting renal tumor.
2. Use of antibiotics within the past two weeks.
3. Renal dysfunction (serum creatinine \>451 μmol/L).
4. Unresolved hemorrhage or coagulation abnormalities.
5. Patients who have undergone percutaneous renal fistula or have a ureteral stent in place on the affected side.
6. Simultaneous bilateral renal stone surgery.
7. Severe underlying diseases, such as respiratory or circulatory insufficiency, that cannot tolerate anesthesia or surgery.
8. Pregnant or lactating women.

Primary outcomes:
measure: Urosepsis
timeFrame: Within 7 days postoperatively
Secondary outcomes:
measure: Fever
timeFrame: Within 7 days postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: GuangGong
Study officials:
References: