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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02961140
Other study ID # 201512052RINB
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 6, 2016
Last updated November 8, 2016
Start date November 2016
Est. completion date November 2019

Study information

Verified date November 2016
Source National Taiwan University Hospital
Contact Ya-jung Cheng, M.D., Ph.D
Phone +886-2-23123456
Email chengyj@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.


Description:

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients diagnosed as esophageal cancer

- Scheduled for minimally invasive esophageal resection and reconstruction

Exclusion Criteria:

- End-stage organ dysfunction, including heart failure, hepatic failure, renal failure

- Arrhythmia

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Cardiac Output Maximization
According to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation.
Cardiac Output Normalization
The investigator will administer intravenous fluids to keep cardiac index (CI) = 2.2, and maintain CI and stroke volume variation during the whole operation.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Ministry of Science and Technology, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative complication Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection 1 month No
Secondary Intraoperative hemodynamic stability Incidence of intraoperative shock, use of vasopressor or inotropic agents 1 day No
Secondary Length of stay Intensive care unit length of stay and hospital stay 1 month No
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