Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?

Sepsis Clinical Trial

Official title:

Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210425
• Other study ID #: 12440100455344205E
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: November 10, 2024

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Yongda Liu, Ph.D
• Phone: 18922347906
• Email: 13719007083[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 10, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Communicable Diseases
• Infections
• Kidney Calculi
• Nephrolithiasis
• Sepsis
• Urinary Tract Infections

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	GuangGong

Sponsors (1)

Lead Sponsor	Collaborator
Junhao Zheng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urosepsis	?Confirmed urinary tract infection; ?SOFA (Sequential Organ Failure Assessment) score =2 points. A diagnosis of urosepsis can be made if both of the above conditions are met.	Within 7 days postoperatively
Secondary	Fever	Postoperative body temperature >38°C	Within 7 days postoperatively