Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy (PPV)

August 28, 2013 updated by: National Taiwan University Hospital

Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation

The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • Department of Anesthesiology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing esophagectomy and reconstruction

Exclusion Criteria:

  • ASA score >= 3, (American Society of Anesthesiologist physical status classification system)
  • arrythmia, atrial fibrillation
  • lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect
  • plasma creatinine level above 1.5 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Restrictive intraoperative fluid therapy
To Keep intraoperative pulse pressure variation above 18%.
Other: Intraoperative fluid therapy
Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.
OTHER: Liberal intraoperative fluid therapy
To keep intraoperative pulse pressure variation below 13%.
Other: Intraoperative fluid therapy
Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative lung function, kidney function, inflammatory response
Time Frame: from introperative to postoperative day 2
plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8
from introperative to postoperative day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative short-term outcome
Time Frame: the duration of hospital stay, about 4 weeks
Respiratory complication, cardiovascular complication, acute renal failure, another complications
the duration of hospital stay, about 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ya-Uyng Cheng, MD. PHD., chengyj@ntu.edu.tw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (ESTIMATE)

September 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201211078RIB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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