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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Contact Information
Primary
Tyler S Garman, MD
tgarman1@jhu.edu
410-955-6100
Backup
Max R Kates, MD
Mkates@jhmi.edu
410-614-0009
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 130
Treatments
Experimental: Home IVF + ERAS
Patients assigned to the home IVF arm will undergo the investigator's current ERAS pathway, which involves establishing vascular access that can be used for 4 weeks at home. Many patients have existing vascular access via a port which the participant receives for neoadjuvant chemotherapy. If the patient does not have existing access, the JHH Vascular Access Team (VAT) is engaged during the post-operative hospitalization to place a midline catheter, which is a type of peripheral vascular access that is adequate for 4 week durations and is less invasive than central catheters. Once the patient has vascular access, the home care coordinator and social worker are engaged to organize home nursing for wound care, ostomy teaching, and home IVF. At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the participant's home nurse.
No_intervention: ERAS Alone
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.
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov