Clinical trial NCT06801405: Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction
Official title: Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Obstruction
Neoplasms
Acute Kidney Injury
Nephrostomy; Complications
Antibiotic Prophylaxis
Urinary Tract Infections
Keywords: antibiotic prophylaxis
percutaneous nephrostomy
urinary tract infections
cancer patients
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for cancer who required percutaneous nephrostomies

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary tract infection rate
timeFrame: Up to 7 days after percutaneous nephrostomy
Secondary outcomes:
Other outcomes:
Locations:
city: Jales
country: Brazil
facility: Jales Cancer Hospital
state: SP
Study officials:
affiliation: Barretos Cancer Hospital
name: Ricardo RD Reis
role: STUDY_CHAIR
References: