Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
NCT ID: NCT02003066
Last Updated: 2019-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2014-03-20
2016-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard
Standard fluid therapy
In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.
Conservative
Conservative fluid therapy
In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.
Interventions
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Standard fluid therapy
In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.
Conservative fluid therapy
In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congestive heart failure
* liver failure
* renal failure
* pregnant woman
* allergy to hydroxyethyl starch solutions
* coagulation abnormalities
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Anesthesiology and Pain Medicine, Yonsei University Health System
Seoul, , South Korea
Countries
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References
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Kim HJ, Kim EJ, Lee HJ, Min JY, Kim TW, Choi EC, Kim WS, Koo BN. Effect of goal-directed haemodynamic therapy in free flap reconstruction for head and neck cancer. Acta Anaesthesiol Scand. 2018 Aug;62(7):903-914. doi: 10.1111/aas.13100. Epub 2018 Mar 25.
Other Identifiers
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4-2013-0638
Identifier Type: -
Identifier Source: org_study_id
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