- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404455
Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft
January 16, 2012 updated by: So Yeon Kim, Severance Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Normal pulse pressure
pulse pressure <60mmHg
|
HES 130/0.4
(VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
|
|
Other: Wide pulse pressure
pulse pressure ≥60mmHg
|
HES 130/0.4
(VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure
Time Frame: 30 min
|
30 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure
Time Frame: 30 min
|
30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
April 1, 2011
First Submitted That Met QC Criteria
July 27, 2011
First Posted (Estimate)
July 28, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 16, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 1-2010-0039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.