Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Recruiting now · Not applicable
Conditions studied: Bladder Cancer, Muscle Invasive Bladder Cancer (MIBC), Muscle Invasive Bladder Cancer Urothelial Carcinoma, Cystectomy
In brief
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.
Key facts
- Study ID
- NCT07225205
- Run by
- Johns Hopkins University
- People needed
- 130
- Starts
- 2025-11-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2025-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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