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

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ClinicalTrials.gov Identifier: NCT01416077
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping

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).

Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: fluid optimisation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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
Study Start Date : October 2011
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416077

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

Responsible Party: Lena Nilsson, MD pHd, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01416077     History of Changes
Other Study ID Numbers: USANOP001
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: June 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