- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419404
Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU
November 11, 2016 updated by: Robert Thiele, MD, University of Virginia
The investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.
Study Overview
Status
Completed
Conditions
Detailed Description
Total to expected enrollment: 70
Study Type
Observational
Enrollment (Actual)
70
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
-
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Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients having cardiac surgery who have a pulmonary artery catheter
Description
Inclusion Criteria:
- TCV-PO post-operative patients with PA catheters
- Must be 18 years of age and older
Exclusion Criteria:
- History of Pulmonary Hypertension
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients having cardiac surgery
Patients having cardiac surgery who have a pulmonary artery catheter will be eligible for inclusion in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiac output
Time Frame: First five hours after surgery
|
Change in cardiac output after intravenous fluids are given
|
First five hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ROBERT H THIELE, M.D., University of Virginia
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
May 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
April 13, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 11, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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