Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

NCT ID: NCT03213574

Last Updated: 2018-04-05

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-04-30

Brief Summary

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Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.

Detailed Description

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Conditions

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Vascular Hypotension Hypovolemia Hypervolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control Group

The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.

Treatment Group

The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm.

Group Type EXPERIMENTAL

Treatment Group

Intervention Type OTHER

FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.

Interventions

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Control Group

Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.

Intervention Type OTHER

Treatment Group

FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management

Exclusion Criteria

* Age less than 18;
* current pregnancy;
* history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
* patient refusal to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Ronak Raval

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5170073

Identifier Type: -

Identifier Source: org_study_id

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