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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive group | Active Comparator | 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. |
|
| Liberal group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrictive group | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maja Karaman Ilić, MD PhD | Clinical Hospital Centre Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb | Zagreb | City of Zagreb | 10 000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26088854 | Derived | Karaman Ilic M, Madzarac G, Kogler J, Stancic-Rokotov D, Hodoba N. Intraoperative volume restriction in esophageal cancer surgery: an exploratory randomized clinical trial. Croat Med J. 2015 Jun;56(3):290-6. doi: 10.3325/cmj.2015.56.290. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restrictive Group | Restrictive group: 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. |
| FG001 | Liberal Group | Liberal group: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restrictive Group | Restrictive group: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | 10 minutes, 6 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restrictive Group | 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. |
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Small number of participants due to small overall number of patients with esophageal cancer treated in our hospital.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maja Karaman Ilić, MD PhD | KBC Zagreb | 00385 1 2385 122 | majakilic1@gmail.com |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
|
| Liberal group | Other | 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. |
|
|
| End of surgery |
| BG001 | Liberal Group | Liberal group: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA score | The American Society of Anesthesiologists (ASA) Physical Status classification system consists of six categories, as described below: ASA PS 1: Normal healthy patient. ASA PS 2: Patients with mild systemic disease. ASA PS 3: Patients with severe systemic disease. ASA PS 4: Patients with severe systemic disease that is a constant threat to life. ASA PS 5: Moribund patients who are not expected to survive without the operation. ASA PS 6: A declared brain-dead patient who organs are being removed for donor purposes. Smaller number is better. | Mean | Standard Deviation | units on a scale |
|
| Body weight | Mean | Standard Deviation | kg |
|
| OG001 |
| Liberal Group |
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. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | μmol/L | 10 minutes, 6 hours |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mmol/L | 10 minutes, 6 hours |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | mmol/L | 10 minutes, 6 hours |
|
|
|
|
| Secondary | Duration of Surgery | Total time of Lewis-Tanner procedure will be measured and compared between two groups. | Posted | Mean | Standard Deviation | minutes | End of surgery. |
|
|
|
|
| Secondary | Total Volume of Administered Intraoperative Fluid | Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups. | Posted | Mean | Standard Deviation | milliliters | End of surgery |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Liberal Group | 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. | 0 | 8 | 0 | 8 |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| t-test, 1 sided |
| 0.410 |
P < 0.05 was considered significant. |
| No |
| Superiority or Other |
| t-test, 1 sided |
| 0.574 |
P < 0.05 was considered significant. |
| No |
| Superiority or Other |
P < 0.05 was considered significant.
| No |
| Superiority or Other |