Trial Outcomes & Findings for Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial (NCT NCT02033213)
NCT ID: NCT02033213
Last Updated: 2014-05-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
10 minutes, 6 hours
Results posted on
2014-05-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
53.91 years
STANDARD_DEVIATION 8.31 • n=99 Participants
|
52.41 years
STANDARD_DEVIATION 13.41 • n=107 Participants
|
53.12 years
STANDARD_DEVIATION 1.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
ASA score
|
2.61 units on a scale
STANDARD_DEVIATION 0.51 • n=99 Participants
|
2.75 units on a scale
STANDARD_DEVIATION 0.46 • n=107 Participants
|
2.71 units on a scale
STANDARD_DEVIATION 0.48 • n=206 Participants
|
|
Body weight
|
70.01 kg
STANDARD_DEVIATION 18.91 • n=99 Participants
|
66.31 kg
STANDARD_DEVIATION 12.61 • n=107 Participants
|
68.11 kg
STANDARD_DEVIATION 17.61 • n=206 Participants
|
PRIMARY outcome
Timeframe: 10 minutes, 6 hoursAt 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.
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
10 minutes
|
345.01 mmHg
Standard Deviation 35.31
|
330.11 mmHg
Standard Deviation 34.71
|
|
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
6 hours
|
315.51 mmHg
Standard Deviation 32.91
|
307.11 mmHg
Standard Deviation 30.31
|
PRIMARY outcome
Timeframe: 10 minutes, 6 hoursAt 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.
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Creatinine Values During and After Esophageal Carcinoma Surgery
10 minutes
|
91.91 μmol/L
Standard Deviation 12.67
|
90.88 μmol/L
Standard Deviation 14.99
|
|
Creatinine Values During and After Esophageal Carcinoma Surgery
6 hours
|
93.51 μmol/L
Standard Deviation 16.37
|
100.88 μmol/L
Standard Deviation 18.33
|
PRIMARY outcome
Timeframe: 10 minutes, 6 hoursAt 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.
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Lactate Values During and After Esophageal Carcinoma Surgery
10 minutes
|
3.93 mmol/L
Standard Deviation 1.33
|
3.26 mmol/L
Standard Deviation 1.25
|
|
Lactate Values During and After Esophageal Carcinoma Surgery
6 hours
|
2.69 mmol/L
Standard Deviation 0.91
|
2.40 mmol/L
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: 10 minutes, 6 hoursAt 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).
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
10 minutes
|
3.93 mmol/L
Standard Deviation 1.33
|
3.26 mmol/L
Standard Deviation 1.25
|
|
Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
6 hours
|
2.69 mmol/L
Standard Deviation 0.91
|
2.40 mmol/L
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: End of surgery.Total time of Lewis-Tanner procedure will be measured and compared between two groups.
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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.
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|---|---|---|
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Duration of Surgery
|
275.61 minutes
Standard Deviation 91.21
|
324.41 minutes
Standard Deviation 116.61
|
SECONDARY outcome
Timeframe: End of surgeryTotal volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.
Outcome measures
| Measure |
Restrictive Group
n=8 Participants
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
n=8 Participants
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 Volume of Administered Intraoperative Fluid
|
2823.75 milliliters
Standard Deviation 965.8
|
3960.00 milliliters
Standard Deviation 755.9
|
Adverse Events
Restrictive Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liberal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place