Intravenous Fluids for Bladder Cancer

Overseen By Tyler S Garman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Benign indications, Non-bladder malignancy, Advanced disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 34

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding home intravenous fluids (IVF) after bladder cancer surgery can reduce complications and hospital readmissions. It focuses on patients with bladder cancer undergoing a standard surgery called radical cystectomy. Participants will either follow a special recovery plan with home IVF or the same recovery plan without IVF. The trial aims to determine if home IVF aids recovery and prevents hospital readmissions. This trial suits those with confirmed bladder cancer opting for this specific surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative recovery strategies and potentially improve post-surgery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the home intravenous fluid infusion is safe for bladder cancer patients?

Studies have shown that receiving intravenous fluid (IVF) treatments at home can be safe for patients needing ongoing care, such as those recovering from surgery. Research indicates that home treatments can be as safe as those given in a hospital. One study found that the safety of home infusions is similar to hospital infusions.

However, improper fluid management can lead to issues like hyponatremia, where sodium levels in the body become too low. This underscores the need for proper monitoring.

In this trial, fluids are administered at home using a less invasive method called a midline catheter. This method is generally well-tolerated and can be safely used for up to four weeks. For any questions or concerns, consult the trial team or your healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing post-operative care for bladder cancer patients through home intravenous fluid infusion. Unlike the standard ERAS protocol which typically involves hospital-based care, this method allows patients to receive a 1-liter fluid bolus of lactated ringers or normal saline at home, providing more convenience and potentially improving recovery by maintaining hydration and reducing hospital visits. This approach leverages existing vascular access for chemotherapy, or uses a less invasive midline catheter, making it a more patient-friendly option. The trial could offer insights into whether this home-based care reduces complications and improves quality of life compared to traditional methods.

What evidence suggests that home intravenous fluid infusion is effective for bladder cancer recovery?

This trial will compare the use of home intravenous fluids (IVF) with an Enhanced Recovery After Surgery (ERAS) protocol to ERAS alone for patients after bladder cancer surgery. Research has shown that using IV fluids at home after bladder surgery might help reduce complications. Dehydration commonly occurs after surgery and can lead to complications and more hospital visits. Studies have found that maintaining fluid balance can aid recovery and lower these risks. Although specific data on using IV fluids at home after bladder cancer surgery is limited, their use after surgery is generally accepted for its benefits. This method is believed to help keep patients hydrated, potentially improving recovery. ^{1 5 6 7 8}

Who Is on the Research Team?

Max Kates, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone radical cystectomy, a surgery for muscle invasive bladder cancer. Participants must be willing to follow an Enhanced Recovery After Surgery (ERAS) protocol and may need to receive home intravenous fluids. Specific eligibility criteria are not provided.

Inclusion Criteria

I am over 18 years old.

My cancer is a type of bladder cancer confirmed by a pathology report.

I have chosen to have surgery to remove my bladder and nearby lymph nodes after talking with a cancer surgeon.

Exclusion Criteria

I cannot have IVF at home due to heart, kidney, or liver problems.

I am willing and able to participate in follow-up calls.

I am having bladder surgery for non-cancer reasons like pain or severe symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Surgery and Initial Recovery

Participants undergo radical cystectomy and initial recovery in the hospital

1-2 weeks

Inpatient stay

Home Intravenous Fluid Infusion

Participants receive home intravenous fluid infusion as part of the ERAS protocol

4 weeks

3 visits per week (home nursing)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including phone calls at 30 and 90 days post-operatively

90 days

Phone calls at 30 and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Home Intravenous Fluid Infusion

Trial Overview The study tests if adding a home IV fluid program after radical cystectomy reduces hospital readmissions and complications. Patients will either follow the ERAS protocol with additional IV fluids at home or the ERAS protocol alone.

How Is the Trial Designed?

Group I: Home IVF + ERAS Experimental Treatment 2 Interventions

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.

Group II: ERAS Alone Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225205

Home Intravenous Fluid Infusion After Undergoing Radical ... The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications. Detailed Description.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2440939/

Intravesical Treatments of Bladder Cancer: Review - PMC The results show that, compared to MMC alone, electromotive MMC significantly improved the recurrence-free rate (58% vs 31% at 6 months, p = 0.012) and ...

3. urotoday.com urotoday.com/video-lectures/health-policy-in-urological-diseases/video/5072-a-trial-of-in-home-intravesical-therapy-delivery-for-non-muscle-invasive-bladder-cancer-timothy-lyon.html

A Trial of In-Home Intravesical Therapy Delivery for Non- ... Daniel Joyce and Timothy Lyon discuss approaches to reduce treatment burden in non-muscle invasive bladder cancer through the INVITE trial ...

4. urologytimes.com urologytimes.com/view/the-potential-for-in-home-intravesical-therapy-for-nmibc

The potential for in-home intravesical therapy for NMIBC Lyon, MD, FACS, explains what led to the research discussed in his Journal of Urology letter 1 on the potential for in-home intravesical therapy ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07048496

Intravesical Treatment of Bladder Cancer at Home, Multi ... Study Details | NCT07048496 | Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support | ClinicalTrials.gov.

6. nhia.org nhia.org/infusing-safety-comparing-oncology-infusion-outcomes-at-home-infusion-services-vs-hospital-based-outpatient-infusion-centers/

Infusing Safety: Comparing Oncology Infusion Outcomes at ... This study compares safety outcomes of oncology infusions administered through home infusion (HI) to those administered in HOPDs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9844368/

The Prevalence and Indications of Intravenous ... Moreover, incorrect management of fluid assessment and monitoring is associated with adverse outcomes such as hyponatremia (sodium concentration ...

8. pharmacytimes.com pharmacytimes.com/view/home-based-intravenous-cancer-therapies-the-benefits-and-disadvantages

Home-Based Intravenous Cancer Therapies: The Benefits ... Home infusion within the larger ambulatory infusion setting poses specific advantages and disadvantages in relation to other available location options.