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

Study Overview
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Brief Summary
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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).

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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: fluid optimisation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard treatment<br>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<br>Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised | Other: fluid optimisation<br>* Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised Crystalloid infusion (2,5 ml/kg/t) throughout surgery 3 ml/kg Volulyte (synthetic 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. If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI > 2,5. If despite CI > 2,5 Mean Arterial Pressure <65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications 5 and 30 days postoperatively |  | 5 and 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay ICU and total hospital |  | 30 days | 
| return of bowel function |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid, goal-directed, FloTrac, pulse contour analysis, postoperative complications, anesthesia, esophagus