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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01819571

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01819571     History of Changes
Other Study ID Numbers: 1-2011-0056
Study First Received: March 14, 2013
Last Updated: February 17, 2014
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014