Clinical trial · Interventional
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Minimally invasive surgical methods have ceased enrollment
Summary
Brief summary (as posted)
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal Directed Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Goal Directed Therapy
- description
- In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.
- interventionNames
- Device: Goal Directed Therapy
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Standard of care will be used to manage blood pressures.
Primary outcomes (1)
- measure
- Number of Participants With Cardiopulmonary Complications
- timeFrame
- 7 days
- description
- Any documented cardiopulmonary complications present upon chart review.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years of age or older * Patients undergoing primary resection of esophageal cancer and resultant esophagectomy. Exclusion Criteria: * Patients \< 55kg or \> 140 kg, based on literature regarding accuracy of FloTrac. * Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation). * Patients with diagnosed NYHA class III-IV failure or documented EF \< 30% * Patients who are unable/unwilling to consent for study procedures
References
Publications (0)
Data not yet available