The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation
ERAS
1 other identifier
interventional
120
1 country
1
Brief Summary
The goals of this study are to testify the effectiveness on enhancement recovery by new anesthetic ERAS (Enhanced recovery after surgery) strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJune 5, 2017
May 1, 2017
2.7 years
May 11, 2017
June 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications
Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications
within 1 year after operation
Secondary Outcomes (3)
Kidney injuries
Preoperative to postoperative day 1
Lung injuries
Preoperative to postoperative day 1
Inflammatory markers
Preoperative to postoperative day 1
Study Arms (2)
Fluid therapy optimization
EXPERIMENTALFluid loading to optimize stroke volume after induction.
Fluid therapy normalization
NO INTERVENTIONNo fluid loading after induction.
Interventions
colloid 250 mL bolus to increase stroke volume index (SVI). If the increase of SVI is more than 10% of baseline, repeat the bolus. If the increase of SVI is less than 10% of baseline, stop the bolus.
Eligibility Criteria
You may qualify if:
- Patients with esophageal cancer
- Patients will undergo video-assisted thoracic surgical (VATS) esophagectomy and laparoscopic gastric tube reconstruction
You may not qualify if:
- History of arrhythmia
- History of chronic obstructive pulmonary disease (COPD)
- With poor lung function test (FEV1 \< 70% or FEV1/ forced vital capacity (FVC) \< 70% of predicted)
- Preoperative creatinine more than 1.5 mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Test2, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ya-Jung Cheng
Anesthesiology Department, NTUH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
June 5, 2017
Study Start
June 15, 2017
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
June 5, 2017
Record last verified: 2017-05