NCT02419404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

May 1, 2013

Last Update Submit

November 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac output

    Change in cardiac output after intravenous fluids are given

    First five hours after surgery

Study Arms (1)

Patients having cardiac surgery

Patients having cardiac surgery who have a pulmonary artery catheter will be eligible for inclusion in this study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having cardiac surgery who have a pulmonary artery catheter

You may qualify if:

  • TCV-PO post-operative patients with PA catheters
  • Must be 18 years of age and older

You may not qualify if:

  • History of Pulmonary Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ROBERT H THIELE, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Anesthesiology

Study Record Dates

First Submitted

May 1, 2013

First Posted

April 17, 2015

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations