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

NCT ID: NCT06801405

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2024-10-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

No antibiotic prophylaxis (NAP) - Group

No antibiotic prophylaxis before percutaneous nephrostomy

No interventions assigned to this group

Antibiotic prophylaxis (AP) - Group

With antibiotic prophylaxis before percutaneous nephrostomy

antibiotic prophylaxis

Intervention Type: DRUG

Antibiotic prophylaxis before percutaneous nephrostomy

Interventions

antibiotic prophylaxis

Antibiotic prophylaxis before percutaneous nephrostomy

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeferson Rodrigo Zanon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo RD Reis

Role: STUDY_CHAIR

Barretos Cancer Hospital

Locations

Jales Cancer Hospital

Jales, São Paulo, Brazil

Countries

Brazil

Other Identifiers

44395921.4.0000.5437

Identifier Type: -

Identifier Source: org_study_id