Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

• Sponsor: Klinički Bolnički Centar Zagreb (Other)
• Overall Status: Completed
• CT.gov ID: NCT02033213
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasm	Other: Restrictive group; Other: Liberal group	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Restrictive group 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; 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.; Other Names: Intraoperative restrictive fluid management
Active Comparator: Liberal group 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; 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.; Other Names: Intraoperative liberal fluid management

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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 Outcome Measures

1. Duration of Surgery [End of surgery.]

   Total time of Lewis-Tanner procedure will be measured and compared between two groups.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb	Zagreb	City of Zagreb	Croatia	10 000

Sponsors and Collaborators

• Klinički Bolnički Centar Zagreb

Investigators

• Principal Investigator: Maja Karaman Ilić, MD PhD, Clinical Hospital Centre Zagreb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maja Karaman Ilić, MD PhD, Klinički Bolnički Centar Zagreb
• ClinicalTrials.gov Identifier: NCT02033213
• Other Study ID Numbers: JORTK3
• First Posted: Jan 10, 2014
• Last Update Posted: May 26, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Maja Karaman Ilić, MD PhD, Klinički Bolnički Centar Zagreb: intraoperative; fluid management; esophageal carcinoma; surgery; gas exchange; tissue perfusion
• Additional relevant MeSH terms: Carcinoma; Esophageal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Restrictive Group	Liberal Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	8	8	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.91 (8.31)	52.41 (13.41)	53.12 (1.81)
Sex: Female, Male (Count of Participants)
Female	2 25%	4 50%	6 37.5%
Male	6 75%	4 50%	10 62.5%
ASA score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.61 (0.51)	2.75 (0.46)	2.71 (0.48)
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	70.01 (18.91)	66.31 (12.61)	68.11 (17.61)

Outcome Measures

1. Primary Outcome

Title	Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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.	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.
Measure Participants	8	8
10 minutes	345.01 (35.31)	330.11 (34.71)
6 hours	315.51 (32.91)	307.11 (30.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement was assessed at 10 minutes time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.410
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement was assessed at 6 hours time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.621
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

Title	Creatinine Values During and After Esophageal Carcinoma Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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.	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.
Measure Participants	8	8
10 minutes	91.91 (12.67)	90.88 (14.99)
6 hours	93.51 (16.37)	100.88 (18.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement was assessed at 10 minutes time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.791
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement was assessed at 6 hours time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.410
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

3. Primary Outcome

Title	Lactate Values During and After Esophageal Carcinoma Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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.	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.
Measure Participants	8	8
10 minutes	3.93 (1.33)	3.26 (1.25)
6 hours	2.69 (0.91)	2.40 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement aws assessed at 10 minutes time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.322
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments	The measurement was assessed at 6 hours time point.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.574
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

4. Primary Outcome

Title	Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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.	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.
Measure Participants	8	8
10 minutes	3.93 (1.33)	3.26 (1.25)
6 hours	2.69 (0.91)	2.40 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Liberal Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.096
	Comments	P < 0.05 was considered significant.
	Method	t-test, 1 sided
	Comments

5. Secondary Outcome

Title	Duration of Surgery
Description	Total time of Lewis-Tanner procedure will be measured and compared between two groups.
Time Frame	End of surgery.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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. 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.	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. 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.
Measure Participants	8	8
Mean (Standard Deviation) [minutes]	275.61 (91.21)	324.41 (116.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.362
	Comments
	Method	t-test, 1 sided
	Comments

6. Secondary Outcome

Title	Total Volume of Administered Intraoperative Fluid
Description	Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.
Time Frame	End of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restrictive Group	Liberal Group
Arm/Group Description	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. 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.	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. 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.
Measure Participants	8	8
Mean (Standard Deviation) [milliliters]	2823.75 (965.8)	3960.00 (755.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restrictive Group, Liberal Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Arm/Group Title	Restrictive Group		Liberal Group
Arm/Group Description	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.		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.
All Cause Mortality
	Restrictive Group		Liberal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Restrictive Group		Liberal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Restrictive Group		Liberal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

Small number of participants due to small overall number of patients with esophageal cancer treated in our hospital.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.