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

NCT ID: NCT01933451

Last Updated: 2013-09-02

Basic Information

• 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

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

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

Other Complications of Esophagostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

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

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

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ya-Uyng Cheng, MD. PHD.

Role: PRINCIPAL_INVESTIGATOR

chengyj@ntu.edu.tw

Locations

Department of Anesthesiology, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201211078RIB

Identifier Type: -

Identifier Source: org_study_id