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Fluid Management Strategies for Bladder Cancer Surgery

Phase 3
Waitlist Available
Led By Vittoria Arslan-Carlon, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who undergo an open, elective radical cystectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing different amounts of fluid given during surgery to see which prevents delayed bowel function after surgery the best, in order to shorten hospital stays.

Who is the study for?
This trial is for adults aged 21 or older who can consent to participate and are scheduled for elective open bladder surgery (radical cystectomy). It's not suitable for patients with active heart rhythm problems, pregnant women, those with ascites (fluid in the abdomen), or individuals with a BMI over 45 or under 17.Check my eligibility
What is being tested?
The study compares two ways of managing fluids during bladder surgery: one uses a device called EV1000 to guide fluid levels, while the other follows standard practice. The goal is to see which method best prevents slow bowel function post-surgery.See study design
What are the potential side effects?
Potential side effects may include complications from receiving too much or too little fluid during surgery such as dehydration, electrolyte imbalance, swelling due to excess fluids, and possible impact on recovery time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for or have had a major bladder surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
incidence of postoperative ileus (POI)
Secondary outcome measures
compare total volume of fluid
complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Goal directed fluid therapy (GDT)Experimental Treatment1 Intervention
In the GDT arm, patient's SV will be optimized before induction with crystalloid boluses prior to induction of general anesthesia. The GDT arm will have fluid therapy guided by the Edwards EV1000-clinical platform and maintenance crystalloid fluid will be 3cc/kg/h. During the surgical procedure when SVV rises above 12 an albumin bolus will be administered at 250 ml increments until the SVV falls below 8. Transfusion will follow transfusion criteria.
Group II: Standard fluid managementActive Control1 Intervention
The non-intervention group will receive maintenance crystalloid fluid at 10cc/kg/h. Blood loss will be replaced 1:1 with albumin. Transfusion will follow transfusion criteria. Fluid management will not be dependent on the EV1000

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,338 Total Patients Enrolled
Vittoria Arslan-Carlon, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

fluid management guided by the EV1000 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02145871 — Phase 3
Bladder Cancer Clinical Trial 2023: fluid management guided by the EV1000 Highlights & Side Effects. Trial Name: NCT02145871 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a lot of hospitals conducting this trial in North America?

"There are 5 different enrolment sites for this study which are situated in Basking Ridge, Middletown, Commack and 2 other locations. To cut down on travel, you should select the clinical trial site nearest to your residence."

Answered by AI

Is the EV1000 able to help clinicians manage fluids for their patients?

"The EV1000 has been studied in multiple Phase 3 trials, so Power has given it a safety score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
2014. "A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02145871.
~26 spots leftby Apr 2025
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