Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

NCT07225205 | Recruiting

• 1 other identifier: IRB00516342
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bladder Cancer; Muscle Invasive Bladder Cancer (MIBC); Muscle Invasive Bladder Cancer Urothelial Carcinoma; Cystectomy

Keywords

Cystectomy; Bladder Cancer; Muscle Invasive Bladder Cancer (MIBC); Fluids; IVF; ERAS

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with 90-day Hospital Readmission

  The primary outcome will be 90-day hospital readmissions that are unplanned, including admissions for observation

  From date of surgery up to 90-days postoperatively

Secondary Outcomes (3)

• Percentage of participants with 30-day hospital readmissions

  From date of surgery up to 30-days post-operatively

• Percentage of participants with 90-day emergency department presentations

  From date of surgery up to 90 days after surgery

• Percentage of participants with All-cause Complications

  From surgery up to 90 days post surgery

Study Arms (2)

Home IVF + ERAS

EXPERIMENTAL

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.

Other: Intravenous fluids; Other: ERAS

ERAS Alone

NO INTERVENTION

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.

Interventions

Intravenous fluids OTHER

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.

Home IVF + ERAS

ERAS OTHER

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.

Home IVF + ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Max Kates, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler S Garman, MD

CONTACT

410-955-6100; tgarman1@jhu.edu

Max R Kates, MD

CONTACT

410-614-0009; Mkates@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)