Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock

Phase 4TerminatedNCT00535821

Loma Linda University5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Sepsis Septic Shock

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Loma Linda University

Loma Linda, California, United States

VA Loma Linda Health Care System

Loma Linda, California, United States

University of Massachusetts

Worcester, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States