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Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT02033213
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Maja Karaman Ilić, Klinički Bolnički Centar Zagreb

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Intraoperative liberal fluid management




Primary Outcome Measures :
  1. Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: End of surgery. ]
    Total time of Lewis-Tanner procedure will be measured and compared between two groups.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033213


Locations
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Croatia
Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb
Zagreb, City of Zagreb, Croatia, 10 000
Sponsors and Collaborators
Klinički Bolnički Centar Zagreb
Investigators
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Principal Investigator: Maja Karaman Ilić, MD PhD Clinical Hospital Centre Zagreb

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maja Karaman Ilić, MD PhD, Klinički Bolnički Centar Zagreb
ClinicalTrials.gov Identifier: NCT02033213     History of Changes
Other Study ID Numbers: JORTK3
First Posted: January 10, 2014    Key Record Dates
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014
Last Verified: April 2014
Keywords provided by Maja Karaman Ilić, Klinički Bolnički Centar Zagreb:
intraoperative
fluid management
esophageal carcinoma
surgery
gas exchange
tissue perfusion
Additional relevant MeSH terms:
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Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions