Actively Recruiting
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Led by Johns Hopkins University · Updated on 2025-11-20
130
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)
- 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
- Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)
- Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
T
Tyler S Garman, MD
CONTACT
M
Max R Kates, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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