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

NCT01309724 | Completed

• 1 other identifier: 09-1074
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Hypotension; Fluid

Outcome Measures

Primary Outcomes (1)

• Time on vasopressors, measured during the 48 hours after study enrollment

  48 hours after study enrollment

Secondary Outcomes (8)

• ICU length of stay

  At one month (average)

• Hospital length of stay

  At one month (average)

• Duration of mechanical ventilation

  At one month (average)

• Development of acute renal failure

  At one month (average)

• Invasive procedures performed after study enrollment

  At one month (average)

Study Arms (2)

Control

NO INTERVENTION

No measurements are made on the control group.

USCOM

EXPERIMENTAL

Patients undergo hemodynamic measurements with the ultrasound cardiac output monitor (USCOM). Fluid resuscitation is guided by USCOM measurements.

Other: USCOM-guided fluid administration

Interventions

USCOM-guided fluid administration OTHER

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.

Also known as: Ultrasound cardiac output monitor

USCOM

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lee M Demertzis, MD

  Barnes-Jewish Hospital

  PRINCIPAL INVESTIGATOR

• Marin H Kollef, MD

  Washington University School of Medicine

  STUDY DIRECTOR

• Warren Isakow, MD

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 7, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)