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

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ClinicalTrials.gov Identifier: NCT01819571
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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 or disease Intervention/treatment
Fluid Responsiveness Predictability Drug: Fluid loading (Voluven)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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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

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

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

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