Saline Flushing for Nephrostomy

Overseen By Yan Epelboym, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Infection, Anaphylaxis, Pregnancy, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether regular flushing with saline (a saltwater solution) is necessary to keep nephrostomy tubes clear. Nephrostomy tubes drain urine directly from the kidney when a blockage occurs. Participants will be randomly assigned to either continue daily flushing or stop flushing for the study's duration. The trial is intended for individuals who currently have or will soon have a nephrostomy tube placed for ongoing use.

As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance future nephrostomy care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for nephrostomy patients?

Research shows that the safety of regularly flushing nephrostomy tubes with saline hasn't been formally studied, but it is generally considered safe and is widely used. Saline, a simple saltwater solution, is commonly used in medical settings. However, a few potential concerns exist. If not properly filtered, saline can sometimes cause vein irritation or allergic reactions, especially if particles are present.

For nephrostomy tubes specifically, the main risks relate to the tube itself, such as infection or bleeding. These issues are not directly caused by saline flushing but are important for anyone with a nephrostomy tube to be aware of.

Overall, while routine saline flushing is thought to be safe, participants should follow study guidelines and report any unusual symptoms to their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether routine saline flushing of nephrostomy tubes is necessary or if skipping it could be just as safe and effective. Traditionally, nephrostomy care involves regular flushing with saline to prevent blockages, but this trial is investigating if the flushing can be safely omitted. The insights from this study could potentially simplify the care process for patients, reducing the need for daily maintenance and possibly lowering the risk of complications associated with frequent flushing.

What evidence suggests that routine saline flushing is effective for preventing nephrostomy tube obstructions?

This trial will compare routine saline flushing of nephrostomy tubes with no flushing. Studies have shown that regularly flushing nephrostomy tubes with saline is often used to prevent blockages. However, evidence on its effectiveness is mixed. Some research suggests there isn't strong proof that regular flushing reduces blockages. In fact, when comparing blockage rates, no significant difference appeared between those who flushed their tubes regularly and those who didn't. While many patients are advised to flush their tubes to maintain function, the actual benefit might not be as clear as once thought. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients who currently have or will soon have a nephrostomy tube placed as part of their standard care. The study aims to determine if routine saline flushing prevents tube obstructions.

Exclusion Criteria

I have a permanent blood clotting disorder.

History of anaphylaxis to iodinated contrast

Pregnant or intent to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either routine flushing of nephrostomy tubes or no flushing for 12 weeks

12 weeks

1 visit (in-person) for nephrostomy tube placement or exchange

Follow-up

Participants are monitored for nephrostomy tube obstruction or dislodgement at routine exchange or earlier if complications arise

12 weeks

1 visit (in-person) at routine exchange or earlier if needed

What Are the Treatments Tested in This Trial?

Interventions

• Routine Saline Flushing

Trial Overview The study randomly assigns participants to one of two groups: those who will flush their nephrostomy tubes with normal saline routinely, and those who won't flush at all. This process continues for about three months.

How Is the Trial Designed?

Group I: No Flushing of Nephrostomy Experimental Treatment 1 Intervention

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

Group II: Routine Flushing of Nephrostomy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987877?term=TREATMENt

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

2. trial.medpath.com trial.medpath.com/clinical-trial/1e15fbd3f5c9038c/nct06987877-saline-flushing-nephrostomy-tubes-obstruction

Efficacy of Routine Saline Flushing in the Prevention of ... Routine saline flushing of percutaneous nephrostomy tubes is commonly performed at many institutions with the intent of reducing incidences of tube obstruction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1051044313003473

Comparison of tube occlusion rates with and without the ... We find no evidence to support the use of routine saline flushes in patients with PTBD or PCN tubes. The potential benefits of routine saline flushes may not ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6820433/

Heparin flush vs. normal saline flush to maintain the patency ... Consolidated results from eight studies conveyed little favorable effect to maintain patency of CVC with heparin when compared with normal ...

5. healthcare.utah.edu healthcare.utah.edu/radiology/preparing-appointment/interventional-radiology/percutaneous-nephrostomy-tube-care

Caring for Your Percutaneous Nephrostomy Tube You will flush the drain with 5–10cc of sterile saline daily as instructed. Flushing the drain will help keep the tube functioning properly.

6. drugs.com drugs.com/fda-alerts/2410-14699.html

BD Normal Saline Flush Safety Alerts, Recalls & Warnings In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic ...

7. aci.health.nsw.gov.au aci.health.nsw.gov.au/__data/assets/pdf_file/0011/807095/ACI-Management-patients-nephrostomy-tubes-nursing-toolkit.pdf

Management of patients with nephrostomy tubes Flushing of a nephrostomy tube is indicated if: • there is absence of urine in the drainage system. • there is blood in the urine. • flank pain occurs due to a ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/25141-nephrostomy-tube

Nephrostomy Tube: Care, Purpose & Complications What are the risks or complications of a nephrostomy tube? · Bleeding. · Infection. · Injury to your kidney, bladder or ureters. · Allergic reaction ...