NCT07225205Recruiting
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 4 Nov 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Bladder cancer
- NCT number
- NCT07225205
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Nov 2025 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)
Other illness
- Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers).
- Patients with extensive locally advanced disease necessitating a pelvic exenteration
Other
- Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)
- Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
Who the study is looking for
- Adult patients greater than 18 years of age and older
- Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology
- Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.