CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 135 enrolled
Drug / intervention
Standard fluid management +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01596283
NCT01596283Phase 3Completed

A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Memorial Sloan Kettering Cancer Center·interventional·Posted May 10, 2012·Updated Oct 18, 2017

In Brief

A Phase 3 clinical trial evaluating Standard fluid management and Goal directed fluid therapy with the Edwards EV1000 system for Liver Cancer. Completed, enrolled 135 participants across 1 site.

Detailed Summary

The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.1 years ago

Interventions

Standard fluid managementprocedure

The patient will receive standard fluid management

Goal directed fluid therapy with the Edwards EV1000 systemdevice

This arm will have fluid therapy guided by the Edwards EV1000 system.