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Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT07225205 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intravenous fluids
  • ERAS
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Where

2 sites
Johns Hopkins Hospital
Baltimore, United States
Johns Hopkins Hospital
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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