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Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

NCT02033213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-05-26

Study results available
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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.

Conditions

  • Esophageal Neoplasm

Interventions

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

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.

Sponsors & Collaborators

  • Klinički Bolnički Centar Zagreb

    lead OTHER

Principal Investigators

  • Maja Karaman Ilić, MD PhD · Clinical Hospital Centre Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033213 on ClinicalTrials.gov