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Clinical Trials/NCT01416077
NCT01416077
Completed
Phase 4

Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications

University Hospital, Linkoeping1 site in 1 country64 target enrollmentOctober 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
University Hospital, Linkoeping
Enrollment
64
Locations
1
Primary Endpoint
Incidence of complications 5 and 30 days postoperatively
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
October 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

Lena Nilsson

MD pHd

University Hospital, Linkoeping

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of complications 5 and 30 days postoperatively

Time Frame: 5 and 30 days postoperatively

Secondary Outcomes

  • length of stay ICU and total hospital(30 days)
  • return of bowel function(30 days)

Study Sites (1)

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