Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02003066
First received: November 18, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
General Anesthesia
Procedure: Standard fluid therapy
Procedure: Conservative fluid therapy

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 86
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Procedure: 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.
Active Comparator: Conservative Procedure: 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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection

Exclusion Criteria:

  • valvular heart disease
  • congestive heart failure
  • liver failure
  • renal failure
  • pregnant woman
  • allergy to hydroxyethyl starch solutions
  • coagulation abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003066

Contacts
Contact: Bon-Nyeo Koo, MD 82-2-2228-2420 koobn@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon-Nyeo Koo, MD    82-2-2228-2420    koobn@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02003066     History of Changes
Other Study ID Numbers: 4-2013-0638
Study First Received: November 18, 2013
Last Updated: December 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Fluid Therapy
Head and Neck Neoplasms
Surgical Flaps

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014