Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.

Detailed Description
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Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)

Official Title
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Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation

Conditions
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Other Complications of Esophagostomy

Intervention / Treatment
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* Other: Intraoperative fluid therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing esophagectomy and reconstruction Exclusion Criteria: ASA score >= 3, (American Society of Anesthesiologist physical status classification system) arrythmia, atrial fibrillation lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect plasma creatinine level above 1.5 mg/dl

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restrictive intraoperative fluid therapy<br>To Keep intraoperative pulse pressure variation above 18%. | Other: Intraoperative fluid therapy<br>* Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.<br>|
| Other: Liberal intraoperative fluid therapy<br>To keep intraoperative pulse pressure variation below 13%. | Other: Intraoperative fluid therapy<br>* Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative lung function, kidney function, inflammatory response | plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8 | from introperative to postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative short-term outcome | Respiratory complication, cardiovascular complication, acute renal failure, another complications | the duration of hospital stay, about 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid therapy, Intraoperative care, Patient Outcome Assessment, pulse pressure variation, restrictive fluid therapy, goal-directed fluid therapy, esophagectomy