Hemodynamic Optimization By Non-Invasive Determination Of Cardiac Output In Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309724
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : March 7, 2011
Information provided by:
Washington University School of Medicine

Brief Summary:
Inadequate identification of and subsequent delayed therapy for patients with hypoperfusion (including hypovolemia, congestive heart failure and sepsis) is a common problem faced by physicians and intensivists caring for critically ill patients. Bedside clinical assessment is notoriously inaccurate in diagnosing complex etiologies of hemodynamic disturbances and in deciding on the appropriate therapy. Invasive techniques which are often required to guide diagnosis and therapy have significant risks associated with them, are costly, and are time consuming. New technology has been developed that allows for instantaneous, noninvasive monitoring of key hemodynamic parameters, like stroke volume, peak velocity and cardiac output. This new technology has the potential to improve recognition of the etiology of hemodynamic disturbances and assist the clinician in optimizing therapy based on changes in hemodynamic parameters. There is significant potential for this to be translated into improved outcomes in critically ill patients, but this has never been studied.

Condition or disease Intervention/treatment Phase
Hypotension Other: USCOM-guided fluid administration Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arm Intervention/treatment
No Intervention: Control
No measurements are made on the control group.
Experimental: USCOM
Patients undergo hemodynamic measurements with the ultrasound cardiac output monitor (USCOM). Fluid resuscitation is guided by USCOM measurements.
Other: USCOM-guided fluid administration
Patients in the intervention group underwent hemodynamic measurements with the ultrasound cardiac output monitor. Based on these measurements, patients were guided through a fluid resuscitation protocol.
Other Name: Ultrasound cardiac output monitor

Primary Outcome Measures :
  1. Time on vasopressors, measured during the 48 hours after study enrollment [ Time Frame: 48 hours after study enrollment ]

Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: At one month (average) ]
  2. Hospital length of stay [ Time Frame: At one month (average) ]
  3. Duration of mechanical ventilation [ Time Frame: At one month (average) ]
  4. Development of acute renal failure [ Time Frame: At one month (average) ]
  5. Invasive procedures performed after study enrollment [ Time Frame: At one month (average) ]
  6. Intravenous fluids infused in first 2 hours after enrollment [ Time Frame: First 2 hours after study enrollment ]
  7. Intravenous fluids infused in first 48 hours after enrollment [ Time Frame: First 48 hours after study enrollment ]
  8. Need for hemodialysis [ Time Frame: At one month (average) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 yrs or greater
  • Administration of vasopressors, defined as a continuous infusion of norepinephrine at a dose >5 mcg/min, dopamine ≥5 mcg/kg/min or any dose of another vasopressor
  • Passage of <18 hours since initiation of vasopressors at doses specified above

Exclusion Criteria:

  • Hemorrhagic shock
  • Need for immediate surgery
  • Imminent risk of death in the next 48 hours (as judged by the attending ICU physician)
  • Level of care decision that precluded implementation of the study protocol
  • Enrollment in any other clinical study
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309724

United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Lee M Demertzis, MD Barnes-Jewish Hospital
Study Director: Marin H Kollef, MD Washington University School of Medicine
Study Director: Warren Isakow, MD Washington University School of Medicine

Responsible Party: Lee M Demertzis, M.D., Barnes-Jewish Hospital Identifier: NCT01309724     History of Changes
Other Study ID Numbers: 09-1074
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases