A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-21

Study Completion Date

2024-03-14

Brief Summary

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The purpose of this study is to help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong hospital stay.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard fluid management

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

Group Type ACTIVE_COMPARATOR

standard fluid management

Intervention Type OTHER

Goal directed fluid therapy (GDT)

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 Type EXPERIMENTAL

fluid management guided by the EV1000

Intervention Type OTHER

Interventions

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standard fluid management

Intervention Type OTHER

fluid management guided by the EV1000

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (21 years old or greater) who are able to provide informed consent
* Patients who undergo an open, elective radical cystectomy

Exclusion Criteria

* Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
* Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
* Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy
* BMI \> 45 or \<17, because increased abdominal pressure interferes with EV1000 reading accuracy

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No