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WithdrawnNCT04310904CardioLogUpdated Jun 15, 2026

Cardiac Output Assessment by Using Saline Contrast Injection

An observational study in Echocardiography, sponsored by Centre Hospitalier Universitaire, Amiens. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Why this study was withdrawn
Difficult recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

Read the detailed description

The investigators decided to conduct a prospective observational study to compare contrast assessment of CO and cardiac Doppler technique. Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

02

Conditions studied

  • Echocardiography

Keywords

  • echocardiography
  • Doppler cardiac output
  • contrast
  • thermodilution
  • agitated saline
  • ICU
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Inclusion criteria

  • all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Exclusion criteria

Exclusion Criteria:

  • patients under 18 years old
  • pregnant patients
  • moribund patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU cardiac output (CO) assessment patients

    all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

    Other: contrast assessment of cardiac output (CO) · Other: cardiac Doppler technique

Interventions

  • Othercontrast assessment of cardiac output (CO)

    Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

  • Othercardiac Doppler technique

    Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

06

What researchers measure

Primary outcomes

  1. variation of cardiac output assessment (CO)

    correlation will be done between contrast and the reference method cardiac Doppler method.

    Time frame: day 0

Secondary outcomes

  1. variation of cardiac output assessment (CO) in patients with a swan gaz catheter

    comparison will be performed between the contrast CO and the thermodilution CO in the group of patients with a swan ganz catheter

    Time frame: day 0

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04310904
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Mar 17, 2020
Start date
Mar 6, 2019
Primary completion
Mar 2024 (estimated)
Completion
Mar 10, 2026
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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