Efficacy of Routine Saline Flushing in the Prevention of Nephrostomy Tube Obstructions: A Pilot Study

NCT06987877 | Recruiting

• 1 other identifier: 2024p003079
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators performing this research to study if routine flushing is necessary to prevent obstructions of a nephrostomy tube. This study will evaluate patients that have nephrostomy tube or will have nephrostomy tubes placed as part of their standard clinical care. If participants agree to participate in this study, participants will undergo randomized assignment to either continue to routinely flush the nephrostomy tube with normal saline or not to routinely flush the nephrostomy tube with normal saline. Participantswill be in the study for approximately 3 months if they decide to stay for the whole study.

Conditions

Nephrostomy

Keywords

Nephrostomy occlusion

Outcome Measures

Primary Outcomes (1)

• Tube Obstruction

  The primary endpoint is the difference in rate of nephrostomy tube obstructions prior to 12-week routine maintenance exchanges in the intervention and control groups.

  12 weeks

Secondary Outcomes (1)

• Tube Dislodgement

  12 weeks

Study Arms (2)

Routine Flushing of Nephrostomy

ACTIVE COMPARATOR

Subjects in the routine flushing group will continue to flush their nephrostomy tubes once per day with 10mL of normal saline

Other: Flushing of nephrostomy

No Flushing of Nephrostomy

EXPERIMENTAL

Subjects allocated to the study intervention group will not flush their nephrostomy tube during the duration of the research study

Other: No flushing of the nephrostomy

Interventions

Flushing of nephrostomy OTHER

Subjects assigned to this cohort will flush their nephrostomy catheter once daily with 10 mL of normal saline

Routine Flushing of Nephrostomy

No flushing of the nephrostomy OTHER

Subjects allocated to the study intervention group will not flush their nephrostomy tube during the duration of the research study

No Flushing of Nephrostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80, with planned nephrostomy tube exchange or new nephrostomy tube placement with ongoing need for a nephrostomy tube.

You may not qualify if:

• Current local infection
• History of anaphylaxis to iodinated contrast
• Pregnant or intent to become pregnant during the study
• Irreversible coagulopathy
• Planned for definitive treatment for the clinical indication of the nephrostomy tube prior to 12-week post-intervention.
• Planned routine exchange prior to 12 weeks after nephrostomy tube exchange or placement procedure
• Complete sensory loss below T10 dermatome.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Yan Epelboym, MD, MPH

  MGB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Epelboym, MD, MPH

CONTACT

617-732-4763; yepelboym@bwh.harvard.edu

Austin Lai, MD

CONTACT

617-732-4763; ALAI4@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)