Expired Study
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Charlottesville, Virginia 22908


Purpose:

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 summary:

Total to expected enrollment: 70


Criteria:

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 is Available At:


Original ID:

16712


NCT ID:

NCT02419404


Secondary ID:


Study Acronym:


Brief Title:

Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU


Official Title:

Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Virginia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

70


Enrollment Type:

Actual


Overall Contact Information

Official Name:ROBERT H THIELE, M.D.
Principal Investigator
University of Virginia

Study Dates

Start Date:May 2013
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:December 2015
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 11, 2016
First Received Date:May 1, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in cardiac output
Time Frame:First five hours after surgery
Safety Issues:False
Description:Change in cardiac output after intravenous fluids are given

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Patients having cardiac surgery
Description:Patients having cardiac surgery who have a pulmonary artery catheter will be eligible for inclusion in this study

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Virginia

Samples and Retentions

Study Population: Patients having cardiac surgery who have a pulmonary artery catheter
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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