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

NCT ID: NCT01933451

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Other Complications of Esophagostomy

Keywords

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fluid therapy Intraoperative care Patient Outcome Assessment pulse pressure variation restrictive fluid therapy goal-directed fluid therapy esophagectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Restrictive intraoperative fluid therapy

To Keep intraoperative pulse pressure variation above 18%.

Group Type EXPERIMENTAL

Intraoperative fluid therapy

Intervention Type OTHER

Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

Liberal intraoperative fluid therapy

To keep intraoperative pulse pressure variation below 13%.

Group Type OTHER

Intraoperative fluid therapy

Intervention Type OTHER

Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

Interventions

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Intraoperative fluid therapy

Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ya-Uyng Cheng, MD. PHD.

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Department of Anesthesiology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201211078RIB

Identifier Type: -

Identifier Source: org_study_id