Phase 3
N=135
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01596283 ↗Enrolled (actual)
135
Serious AEs
51.1%
Results posted
Oct 2017
Primary outcome: Primary: Postoperative Complications — 42; 45; 24; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard fluid management (Procedure); Goal directed fluid therapy with the Edwards EV1000 system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Complications |
42; 45; 24; 24 | — |
| SECONDARY Low Cardiac Output Time |
21; 12 | — |
| SECONDARY Total Volume of Fluid Used Perioperatively |
2.0; 2.9 | — |
| SECONDARY Total Volume of Fluid Used Postoperatively |
0.9; 1.0 | — |
| SECONDARY Postoperative Length of Stay |
7; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults (18 years old or greater) who are able to provide informed consent.
- Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
Exclusion Criteria
- Active coronary disease.
- Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
- Active symptomatic cerebrovascular disease.
- Active congestive heart failure and ejection fraction 1.8)
- Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count 45 or <17
Data sourced from ClinicalTrials.gov (NCT01596283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.