RECRUITINGINTERVENTIONAL

Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

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.

OTHER

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