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The effect of prophylactic antibiotics or empiric antibacterial therapy on infection after PCNL in kidney stone patients with negative urine culture but positive urine routine: a randomized controlled, open-label, non-inferiority, single-center trial

The effect of prophylactic antibiotics or empiric antibacterial therapy on infection after PCNL in kidney stone patients with negative urine culture but positive urine routine: a randomized controlled, open-label, non-inferiority, single-center trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050837
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney stone

Interventions

Experimental group:No antibiotics before surgery
Control group:3 days of antibiotics before surgery

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Negative preoperative urine culture; 3. White blood cells >= 10 /visual field, and/or nitrite positive under high magnification of preoperative urine sediment; 4. Serum creatinine < 133 umol/L; 5. ASA I/II; 6. Renal calculi 2-4 cm.

Exclusion criteria

Exclusion criteria: 1. Patients who had been treated with antibiotics within 4 weeks before operation (oral/intravenous); 2. Patients with fever within 2 weeks before operation; 3. Severe hydronephrosis or chronic urinary retention existed in the kidney; 4. Patients with ureteral calculi and bladder calculi; 5. Patients with abnormal lysis structure (isolated kidney, ectopic kidney, horseshoe kidney, repeated kidney), ureteral stricture and urinary diversion; 6. Ureteral stent implantation, renal fistula patients and indwelling catheter patients; 7. Patients with renal abscess found during operation; 8. Patients who underwent bilateral surgery or ipsilateral ureteral lithotripsy at the same time; 9. Patients with long-term immunosuppressive agents and glucocorticoids; 10. Patients with hypertension and diabetes.

Design outcomes

Primary

MeasureTime frame
Rate of fever;

Secondary

MeasureTime frame
Rate of systemic inflammatory response syndrome (SIRS);Duration of hospital stay;Duration of operation;Complications;

Countries

China

Contacts

Public ContactZeng Guohua

The First Affiliated Hospital of Guangzhou Medical University

gzgyzhongwen@163.com+86 13631320020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026