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Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

RECRUITINGN/ASponsored by Johns Hopkins University
Actively Recruiting
PhaseN/A
SponsorJohns Hopkins University
Started2025-11-01
Est. completion2027-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions5

Bladder CancerCancerCystectomyMuscle Invasive Bladder Cancer (MIBC)Muscle Invasive Bladder Cancer Urothelial Carcinoma

Locations2 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tyler Garman, MD410-955-6100tgarman1@jhu.edu
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tyler S Garman, MD813-955-6100tgarman1@jh.edu

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