Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

Study Overview
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Brief Summary
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An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.

Detailed Description
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A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012. Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid (restrictive group) and another that received > 8 ml/kg/h of fluid (liberal group). Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification > III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy. All patients underwent esophagectomy carried out according to the Lewis-Tanner approach. Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery. ANOVA tests were performed to determine significant differences in mean values between study groups. Independent-sample t-tests were used to test differences in mean values between the restrictive and liberal groups for each of the two sets of measurements separately (10 minutes after anesthesia induction and 6 hr after surgery). P < 0.05 was considered significant.

Official Title
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Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial

Conditions
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Esophageal Neoplasm

Intervention / Treatment
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* Other: Restrictive group
* Other: Liberal group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: esophageal carcinoma Lewis Tanner procedure (median laparotomy and right thoracotomy) Exclusion Criteria: younger than 18 years severe lung disease chronic renal insufficiency a physical status classification > III on the American Society of Anesthesiologists (ASA) scale impossible to perform epidural catheter placement thoraco-phreno-laparotomy

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive group<br>Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. | Other: Restrictive group<br>* A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.<br>* Other names: Intraoperative restrictive fluid management;|
| Active Comparator: Liberal group<br>Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. | Other: Liberal group<br>* A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.<br>* Other names: Intraoperative liberal fluid management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately. | 10 minutes, 6 hours | 
| Creatinine Values During and After Esophageal Carcinoma Surgery | At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately. | 10 minutes, 6 hours | 
| Lactate Values During and After Esophageal Carcinoma Surgery | At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately. | 10 minutes, 6 hours | 
| Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive). | 10 minutes, 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery | Total time of Lewis-Tanner procedure will be measured and compared between two groups. | End of surgery. | 
| Total Volume of Administered Intraoperative Fluid | Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups. | End of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative, fluid management, esophageal carcinoma, surgery, gas exchange, tissue perfusion