NCT01616017

Brief Summary

Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest in less invasive methods of measuring CO. This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution (COUD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 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

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 29, 2012

Last Update Submit

May 25, 2016

Conditions

Cardiac DiseasePost Surgery Patients

Keywords

Cardiac outputultrasound dilutionthermodilution

Outcome Measures

Primary Outcomes (1)

  • Compare Cardiac Output Measurements

    To compare CO measured by ultrasound dilution method (COUD) and pulmonary artery thermodilution technique (COTD) in SICU (Surgical Intensive Care Unit) patients.

    During the stay in the ICU with in situ catheters (expected avg 3 days)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Age ≥ 18 years of age Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

You may qualify if:

  • Age ≥ 18 years of age
  • Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

You may not qualify if:

  • Age \< 18 years of age
  • Patients with structurally abnormal heart (e.g. shunt) (confirmed by history taking)
  • Patients who have heparin allergy. (Confirmed by history taking)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 11, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)