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

November 18, 2013
December 2, 2013
November 2013
August 2015   (final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02003066 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
General Anesthesia
  • 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.
  • 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.
  • Experimental: Standard
    Intervention: Procedure: Standard fluid therapy
  • Active Comparator: Conservative
    Intervention: Procedure: Conservative fluid therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
86
September 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Bon-Nyeo Koo, MD 82-2-2228-2420 koobn@yuhs.ac
Korea, Republic of
 
NCT02003066
4-2013-0638
No
Yonsei University
Yonsei University
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Yonsei University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP