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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

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ClinicalTrials.gov Identifier: NCT01404455
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Stroke Volume Variation Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Study Start Date : December 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure [ Time Frame: 30 min ]

Secondary Outcome Measures :
  1. Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure [ Time Frame: 30 min ]

Eligibility Criteria

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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:

  • 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

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): 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

Responsible Party: So Yeon Kim, MD, PhD, Severance Hospital
ClinicalTrials.gov Identifier: NCT01404455     History of Changes
Other Study ID Numbers: IRB 1-2010-0039
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

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