Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer
Both
Esophageal Cancer
Trial Information
Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications
Inclusion Criteria:
- Patients scheduled for transthoracic esophageal resection because of malignancy,
without colonic interposition who leave informed consent
Exclusion Criteria:
- ASA 4 or 5
- Atrial Fibrillation
- Significant Aortic or Mitral Valve Insufficiency
- Preoperative planned extensive monitoring beyond CVP, arterial blood pressure,
diuresis, ECG and other standard monitors
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence of complications 5 and 30 days postoperatively
Outcome Time Frame:
5 and 30 days postoperatively
Safety Issue:
Yes
Principal Investigator
Lena Nilsson, MD PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital, Linkoeping
Authority:
Sweden: Regional Ethical Review Board
Study ID:
USANOP001
NCT ID:
NCT01416077
Start Date:
October 2011
Completion Date:
September 2013
Related Keywords:
- Esophageal Cancer
- fluid
- goal-directed
- FloTrac
- pulse contour analysis
- postoperative complications
- anesthesia
- esophagus
- Esophageal Diseases
- Esophageal Neoplasms
- Postoperative Complications
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