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NCT Number: NCT02033213

Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

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.

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Key information

Conditions

Esophageal Neoplasm Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10 000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

restrictive group

Other

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

Liberal group

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Klinički Bolnički Centar Zagreb

Other

Registry information

Official study title

Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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