Esophageal Neoplasm
Conditions
Keywords
intraoperative, fluid management, esophageal carcinoma, surgery, gas exchange, tissue perfusion
Brief summary
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
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.
Interventions
OTHERRestrictive 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.
OTHERLiberal 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.
Sponsors
Klinički Bolnički Centar Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | 10 minutes, 6 hours | 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. |
| Creatinine Values During and After Esophageal Carcinoma Surgery | 10 minutes, 6 hours | 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. |
| Lactate Values During and After Esophageal Carcinoma Surgery | 10 minutes, 6 hours | 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. |
| Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | 10 minutes, 6 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Surgery | End of surgery. | Total time of Lewis-Tanner procedure will be measured and compared between two groups. |
| Total Volume of Administered Intraoperative Fluid | End of surgery | Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Liberal Group | Total | Restrictive Group |
|---|---|---|---|
| Age, Continuous | 52.41 years STANDARD_DEVIATION 13.41 | 53.12 years STANDARD_DEVIATION 1.81 | 53.91 years STANDARD_DEVIATION 8.31 |
| ASA score | 2.75 units on a scale STANDARD_DEVIATION 0.46 | 2.71 units on a scale STANDARD_DEVIATION 0.48 | 2.61 units on a scale STANDARD_DEVIATION 0.51 |
| Body weight | 66.31 kg STANDARD_DEVIATION 12.61 | 68.11 kg STANDARD_DEVIATION 17.61 | 70.01 kg STANDARD_DEVIATION 18.91 |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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).
Time frame: 10 minutes, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restrictive Group | Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | 10 minutes | 3.93 mmol/L | Standard Deviation 1.33 |
| Restrictive Group | Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | 6 hours | 2.69 mmol/L | Standard Deviation 0.91 |
| Liberal Group | Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | 10 minutes | 3.26 mmol/L | Standard Deviation 1.25 |
| Liberal Group | Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | 6 hours | 2.40 mmol/L | Standard Deviation 1.08 |
p-value: 0.03t-test, 1 sided
p-value: 0.096t-test, 1 sided
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.
Time frame: 10 minutes, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restrictive Group | Creatinine Values During and After Esophageal Carcinoma Surgery | 10 minutes | 91.91 μmol/L | Standard Deviation 12.67 |
| Restrictive Group | Creatinine Values During and After Esophageal Carcinoma Surgery | 6 hours | 93.51 μmol/L | Standard Deviation 16.37 |
| Liberal Group | Creatinine Values During and After Esophageal Carcinoma Surgery | 10 minutes | 90.88 μmol/L | Standard Deviation 14.99 |
| Liberal Group | Creatinine Values During and After Esophageal Carcinoma Surgery | 6 hours | 100.88 μmol/L | Standard Deviation 18.33 |
Comparison: The measurement was assessed at 10 minutes time point.p-value: 0.791t-test, 1 sided
Comparison: The measurement was assessed at 6 hours time point.p-value: 0.41t-test, 1 sided
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.
Time frame: 10 minutes, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restrictive Group | Lactate Values During and After Esophageal Carcinoma Surgery | 10 minutes | 3.93 mmol/L | Standard Deviation 1.33 |
| Restrictive Group | Lactate Values During and After Esophageal Carcinoma Surgery | 6 hours | 2.69 mmol/L | Standard Deviation 0.91 |
| Liberal Group | Lactate Values During and After Esophageal Carcinoma Surgery | 10 minutes | 3.26 mmol/L | Standard Deviation 1.25 |
| Liberal Group | Lactate Values During and After Esophageal Carcinoma Surgery | 6 hours | 2.40 mmol/L | Standard Deviation 1.08 |
Comparison: The measurement aws assessed at 10 minutes time point.p-value: 0.322t-test, 1 sided
Comparison: The measurement was assessed at 6 hours time point.p-value: 0.574t-test, 1 sided
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.
Time frame: 10 minutes, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restrictive Group | Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | 10 minutes | 345.01 mmHg | Standard Deviation 35.31 |
| Restrictive Group | Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | 6 hours | 315.51 mmHg | Standard Deviation 32.91 |
| Liberal Group | Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | 10 minutes | 330.11 mmHg | Standard Deviation 34.71 |
| Liberal Group | Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | 6 hours | 307.11 mmHg | Standard Deviation 30.31 |
Comparison: The measurement was assessed at 10 minutes time point.p-value: 0.41t-test, 1 sided
Comparison: The measurement was assessed at 6 hours time point.p-value: 0.621t-test, 1 sided
Secondary
Duration of Surgery
Total time of Lewis-Tanner procedure will be measured and compared between two groups.
Time frame: End of surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restrictive Group | Duration of Surgery | 275.61 minutes | Standard Deviation 91.21 |
| Liberal Group | Duration of Surgery | 324.41 minutes | Standard Deviation 116.61 |
p-value: 0.362t-test, 1 sided
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.
Time frame: End of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restrictive Group | Total Volume of Administered Intraoperative Fluid | 2823.75 milliliters | Standard Deviation 965.8 |
| Liberal Group | Total Volume of Administered Intraoperative Fluid | 3960.00 milliliters | Standard Deviation 755.9 |
p-value: 0.02t-test, 1 sided