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

Other Complications of Esophagostomy Clinical Trial

— PPV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01933451
• Other study ID #: 201211078RIB
• Status: Terminated
• Phase: N/A
• First received: March 19, 2013
• Last updated: August 28, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: March 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Other Complications of Esophagostomy

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative lung function, kidney function, inflammatory response	plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8	from introperative to postoperative day 2	Yes
Secondary	postoperative short-term outcome	Respiratory complication, cardiovascular complication, acute renal failure, another complications	the duration of hospital stay, about 4 weeks	Yes