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

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ClinicalTrials.gov Identifier: NCT02003066
Recruitment Status : Unknown
Verified November 2015 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
General Anesthesia Procedure: Standard fluid therapy Procedure: Conservative fluid therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1 month after surgery ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02003066     History of Changes
Other Study ID Numbers: 4-2013-0638
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

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