Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Intravenous fluids
  • ERAS

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators