Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01819571
First received: March 14, 2013
Last updated: February 17, 2014
Last verified: February 2014

March 14, 2013
February 17, 2014
January 2012
October 2013   (final data collection date for primary outcome measure)
predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction. [ Time Frame: 10 minutes after fluid replacement ] [ Designated as safety issue: No ]
After induction of anesthesia and applying mechanical ventilation, hemodynamic parameters (including PPV measured by Philips IntelliVue MP 70®) were recorded
Same as current
Complete list of historical versions of study NCT01819571 on ClinicalTrials.gov Archive Site
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Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction
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The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Fluid Responsiveness Predictability
Drug: Fluid loading (Voluven)
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 8ml / kg loading during 15 minutes after induction of anesthesia on both groups
Other Name: Fluid loading
  • Experimental: Normal diastolic function group
    Intervention: Drug: Fluid loading (Voluven)
  • Active Comparator: Diastolic dysfunction group
    Intervention: Drug: Fluid loading (Voluven)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 20 years
  • scheduled for elective coronary artery bypass grafting
  • normal diastolic function (E/E' < 8) or diastolic dysfunction (E/E' >15) according to preoperative Echocardiographic evaluation

Exclusion Criteria:

  • arrythmia,
  • reduced left ventricular function (ejection fraction < 40%)
  • valvular heart disease requiring concomitant surgical correction
  • pulmonary hypertension (mean pulmonary arterial pressure ≥30 mm Hg)
  • peripheral arterial occlusive disease, pulmonary disease (asthma, chronic obstructive pulmonary disease, and lung resection)
  • end-stage renal disease
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01819571
1-2011-0056
Yes
Yonsei University
Yonsei University
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Yonsei University
February 2014

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