Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable

NCT00354211 | Completed DMC

• 1 other identifier: Study # 2005-06, Revision B
• Study Type: observational
• Target: 392
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comparison to standard of care will shorten the time needed to stabilize the patient. The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability.

Conditions

Cardiac Output, High; Cardiac Output, Low

Keywords

Cardiac Output; Hemodynamic Phenomena

Study Arms (2)

1

FLOTRAC™ SYSTEM

Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)

2

Control Group

Interventions

minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) DEVICE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include patients emergently admitted to the Intensive Care Unit who develop hemodynamic instability within 6 hours of admission.

You may qualify if:

• Patient newly admitted to the ICU due to an emergency unplanned admission.
• Patient diagnosed with hemodynamic instability at or becomes unstable within 6 hours of ICU admission.
• Patient must require an indwelling radial or a femoral artery catheter.
• Patient is included in the study according to the specific regulations of the participating center: this may include a deferred consent, consent by designee, consent by independent physician or a combination thereof.
• Patient must be 18 years old or older.

You may not qualify if:

• Patients with contraindications for the placement of radial, femoral, dorsalis pedis, or other arterial cannula.
• Patients with a pulmonary artery catheter.
• Patients who are hemodynamically stable.
• Patients with history or clinical findings of aortic valve regurgitation.
• Patients being treated with an intra-aortic balloon pump.
• Female patient is pregnant.
• Patient is currently participating in an investigational drug or another device study.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (3)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Tampere Unversity Hospital

Tampere, 33521, Finland

Location

University Hospital Bern (Inselspital)

Bern, 3010, Switzerland

Location

Related Publications (1)

• Takala J, Ruokonen E, Tenhunen JJ, Parviainen I, Jakob SM. Early non-invasive cardiac output monitoring in hemodynamically unstable intensive care patients: a multi-center randomized controlled trial. Crit Care. 2011 Jun 15;15(3):R148. doi: 10.1186/cc10273.

  PMID: 21676229 RESULT

MeSH Terms

Conditions

Cardiac Output, High; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jukka Takala, M.D., Ph.D.

  University Hospital Bern (Inselspital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

CH (1); FI (2)