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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01309724
First received: March 2, 2011
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Hypotension
 Other: USCOM-guided fluid administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HEMODYNAMIC OPTIMIZATION BY NON-INVASIVE DETERMINATION OF CARDIAC OUTPUT IN CRITICALLY ILL PATIENTS: A RANDOMIZED, CONTROLLED TRIAL

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Time on vasopressors, measured during the 48 hours after study enrollment [ Time Frame: 48 hours after study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]
  • Development of acute renal failure [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]
  • Invasive procedures performed after study enrollment [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]
  • Intravenous fluids infused in first 2 hours after enrollment [ Time Frame: First 2 hours after study enrollment ] [ Designated as safety issue: No ]
  • Intravenous fluids infused in first 48 hours after enrollment [ Time Frame: First 48 hours after study enrollment ] [ Designated as safety issue: No ]
  • Need for hemodialysis [ Time Frame: At one month (average) ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309724

Locations
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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
  More Information

No publications provided

Responsible Party: Lee M Demertzis, M.D., Barnes-Jewish Hospital
ClinicalTrials.gov Identifier: NCT01309724     History of Changes
Other Study ID Numbers: 09-1074
Study First Received: March 2, 2011
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Hypotension
Fluid

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

ClinicalTrials.gov processed this record on May 16, 2013