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Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Sponsor: Johns Hopkins University
Summary
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.
Official title: Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-11-01
Completion Date
2028-02-01
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Intravenous fluids
At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the patient's home nurse.
ERAS
Patients assigned to not receive home IVF will receive everything in the investigator's current ERAS protocol except the home intravenous fluid program. Patients without preexisting vascular access will not receive a midline catheter post-operatively, however the participant will still receive home care for skilled nursing who will provide wound care, ostomy teaching, and education about perioperative fluid management.
Locations (2)
Johns Hopkins Hospital
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States