Clinical trial NCT00535821: Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
Official title: A Multi-center Randomized Comparison of a Minimally-invasive Cardiovascular Hemodynamic Optimization (MiCHO) Protocol Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock Patients Presenting to the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Severe Sepsis
Septic Shock
Keywords: Emergency Department
Hemodynamic Optimization
Esophageal Doppler monitoring
Early Goal-Directed Therapy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Wayne State University
name: VA Loma Linda Health Care System
First posted: 2007-09-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early intervention in the treatment of septic shock, including early goal-directed therapy (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its widespread application in the emergency department setting. A minimally invasive protocol utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown to result in similar outcome as EGDT.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>= 18 years old
* Source of infection
* Two or more of systemic inflammatory response syndrome criteria
* Systolic blood pressure \< 90 mmHg after a fluid bolus OR lactate \>= 4 mmol/L
* A central line has been placed for CVP/ScvO2 monitoring

Exclusion Criteria:

* Pregnancy
* Acute stroke
* Acute cardiogenic pulmonary edema
* Status asthmaticus
* Unstable cardiac dysrhythmia
* Active hemorrhage
* Acute seizure
* Drug overdose
* Trauma
* Requiring immediate surgery
* Do-not-resuscitate status

Primary outcomes:
measure: Mortality
timeFrame: hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Health Care System
state: California
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Loma Linda University
name: H. Bryant Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
citation: McKendry M, McGloin H, Saberi D, Caudwell L, Brady AR, Singer M. Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004 Jul 31;329(7460):258. doi: 10.1136/bmj.38156.767118.7C. Epub 2004 Jul 8.
citation: Chytra I, Pradl R, Bosman R, Pelnar P, Kasal E, Zidkova A. Esophageal Doppler-guided fluid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care. 2007;11(1):R24. doi: 10.1186/cc5703.
citation: Gunn SR, Fink MP, Wallace B. Equipment review: the success of early goal-directed therapy for septic shock prompts evaluation of current approaches for monitoring the adequacy of resuscitation. Crit Care. 2005 Aug;9(4):349-59. doi: 10.1186/cc3725. Epub 2005 May 27.