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Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01404455
First received: April 1, 2011
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft


Condition Intervention
Stroke Volume Variation
 Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening

Resource links provided by NLM:

Drug Information available for: Hetastarch
U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal pulse pressure
pulse pressure <60mmHg
 Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
Wide pulse pressure
pulse pressure ≥60mmHg
 Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age ≥ 20
  • 2. elective off-pump coronary artery bypass graft

Exclusion Criteria:

  • 1. arrhythmia
  • 2.EF <40%
  • 3.valvular heart dz
  • 4.pul HTN
  • 5.PAOD
  • 6.lung dz
  • 7.NYHA IV
  • 8.ESRD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404455

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided

Responsible Party: So Yeon Kim, MD, PhD, Severance Hospital
ClinicalTrials.gov Identifier: NCT01404455     History of Changes
Other Study ID Numbers: IRB 1-2010-0039
Study First Received: April 1, 2011
Last Updated: January 16, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013