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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01819571
First Posted: March 27, 2013
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition Intervention
Fluid Responsiveness Predictability Drug: Fluid loading (Voluven)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ]
    After induction of anesthesia and applying mechanical ventilation, hemodynamic parameters (including PPV measured by Philips IntelliVue MP 70®) were recorded


Enrollment: 66
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal diastolic function group 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
Active Comparator: Diastolic dysfunction group 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

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01819571


Locations
Korea, Republic of
Department of anesthesiology and pain medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01819571     History of Changes
Other Study ID Numbers: 1-2011-0056
First Submitted: March 14, 2013
First Posted: March 27, 2013
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
pulse pressure variation
fluid responsiveness
diastolic dysfunction


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