Clinical trial NCT02033213: Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial
Official title: Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasm
Keywords: intraoperative
fluid management
esophageal carcinoma
surgery
gas exchange
tissue perfusion
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
timeFrame: 10 minutes, 6 hours
measure: Creatinine Values During and After Esophageal Carcinoma Surgery
timeFrame: 10 minutes, 6 hours
measure: Lactate Values During and After Esophageal Carcinoma Surgery
timeFrame: 10 minutes, 6 hours
measure: Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
timeFrame: 10 minutes, 6 hours
Secondary outcomes:
measure: Duration of Surgery
timeFrame: End of surgery.
measure: Total Volume of Administered Intraoperative Fluid
timeFrame: End of surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb
state: City of Zagreb
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Maja Karaman Ilić, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.