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Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction

Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06801405
Enrollment
320
Registered
2025-01-30
Start date
2021-04-02
Completion date
2024-10-10
Last updated
2026-05-19

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

Conditions

Acute Kidney Injury, Antibiotic Prophylaxis, Neoplasms, Nephrostomy; Complications, Ureteral Obstruction, Urinary Tract Infections

Keywords

antibiotic prophylaxis, percutaneous nephrostomy, urinary tract infections, cancer patients

Brief summary

This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.

Detailed description

The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted. Definitions: Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present). UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement. UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection. Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given. For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically. For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice. Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.

Interventions

DRUGantibiotic prophylaxis

Antibiotic prophylaxis before percutaneous nephrostomy

Sponsors

Barretos Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients treated for cancer who required percutaneous nephrostomies

Exclusion criteria

* Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures; * Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction * Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes

Design outcomes

Primary

MeasureTime frameDescription
Urinary Tract Infection After Percutaneous Nephrostomy ProcedureUp to 7 days after percutaneous nephrostomyProportion of urinary tract infection after each percutaneous nephrostomy

Countries

Brazil

Contacts

STUDY_CHAIRRicardo RD Reis

Barretos Cancer Hospital

Participant flow

Recruitment details

Data were collected on age, sex, skin colour, number of percutaneous nephrostomies performed, including first placements and catheter replacements. The time spent ill and using the nephrostomy catheter was calculated.

Pre-assignment details

As the same participant can undergo more than one percutaneous nephrostomy procedure, be it placement or replacement, and the aim of the study is to assess the rate of urinary tract infection after percutaneous nephrostomy, this becomes the sampling unit and not the participant. Therefore, the number of participants is 320 and the number of procedures studied is 734, of which 214 (29.2%) were excluded from the analysis due to prior antibiotic use.

Baseline characteristics

Characteristic
Age, Continuous59.04 year-old
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
145 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
74 Participants
Sex: Female, Male
Female
87 Participants
Sex: Female, Male
Male
86 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
53 / 66127 / 153
other
Total, other adverse events
0 / 660 / 153
serious
Total, serious adverse events
0 / 660 / 153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026