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

Not Applicable

Terminated

• Conditions: Other Complications of Esophagostomy
• Interventions: Other: Intraoperative fluid therapy

• Registration Number: NCT01933451
• Lead Sponsor: National Taiwan University Hospital

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)

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted QC: 2013-08-28
• Last Update Submitted: 2013-08-28
• Study First Posted: 2013-09-02
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive intraoperative fluid therapy	Intraoperative fluid therapy	To Keep intraoperative pulse pressure variation above 18%.
Liberal intraoperative fluid therapy	Intraoperative fluid therapy	To keep intraoperative pulse pressure variation below 13%.

Primary Outcome Measures

Name	Time	Method
postoperative lung function, kidney function, inflammatory response	from introperative to postoperative day 2	plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8

Secondary Outcome Measures

Name	Time	Method
postoperative short-term outcome	the duration of hospital stay, about 4 weeks	Respiratory complication, cardiovascular complication, acute renal failure, another complications

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan