Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
1 other identifier
interventional
62
1 country
1
Brief Summary
Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.
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 Mar 2014
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
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedStudy Start
First participant enrolled
March 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2016
CompletedJanuary 28, 2019
January 1, 2019
2 years
November 18, 2013
January 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
1 month after surgery
Study Arms (2)
Standard
EXPERIMENTALConservative
ACTIVE COMPARATORInterventions
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.
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
You may qualify if:
- adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection
You may not qualify if:
- valvular heart disease
- congestive heart failure
- liver failure
- renal failure
- pregnant woman
- allergy to hydroxyethyl starch solutions
- coagulation abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University Health System
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 29574681DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
December 6, 2013
Study Start
March 20, 2014
Primary Completion
March 8, 2016
Study Completion
March 8, 2016
Last Updated
January 28, 2019
Record last verified: 2019-01