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Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

This study has been completed.
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping Identifier:
First received: August 11, 2011
Last updated: December 1, 2015
Last verified: June 2015
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).

Condition Intervention Phase
Esophageal Cancer Other: fluid optimisation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications

Resource links provided by NLM:

Further study details as provided by Lena Nilsson, University Hospital, Linkoeping:

Primary Outcome Measures:
  • Incidence of complications 5 and 30 days postoperatively [ Time Frame: 5 and 30 days postoperatively ]

Secondary Outcome Measures:
  • length of stay ICU and total hospital [ Time Frame: 30 days ]
  • return of bowel function [ Time Frame: 30 days ]

Enrollment: 64
Study Start Date: October 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard treatment
Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.
Active Comparator: goal-directed fluid treatment
Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
Other: fluid optimisation

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

  1. Crystalloid infusion (2,5 ml/kg/t) throughout surgery
  2. 3 ml/kg Volulyte (artifical colloid) is infused during 5 minutes and SV is measured directly before and 5 minutes after. If SV increases more than 10% the dose is repeated until no increase > 10% is observed. A new dose is given if SV decreases more than 10% from the last value.
  3. If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI > 2,5.
  4. If despite CI > 2,5 Mean Arterial Pressure <65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01416077

University Hospital Linkoeping
Linkoeping, Sweden, 58246
Sponsors and Collaborators
University Hospital, Linkoeping
Study Chair: Lena Nilsson, MD PhD University Hospital, Linkoeping
  More Information

Responsible Party: Lena Nilsson, MD pHd, University Hospital, Linkoeping Identifier: NCT01416077     History of Changes
Other Study ID Numbers: USANOP001
Study First Received: August 11, 2011
Last Updated: December 1, 2015

Keywords provided by Lena Nilsson, University Hospital, Linkoeping:
pulse contour analysis
postoperative complications

Additional relevant MeSH terms:
Esophageal Neoplasms
Postoperative Complications
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes processed this record on August 18, 2017