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

NCT00535821 | Terminated Phase 4 Results

• 1 other identifier: 57121
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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.

Conditions

Severe Sepsis; Septic Shock

Keywords

Emergency Department; Hemodynamic Optimization; Esophageal Doppler monitoring; Early Goal-Directed Therapy

Outcome Measures

Primary Outcomes (1)

• Mortality

  In-hospital mortality

  hospital

Study Arms (2)

MiCHO

EXPERIMENTAL

A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)

Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc

EGDT

ACTIVE COMPARATOR

A 6-hour resuscitation protocol utilizing CVP/ScvO2

Device: Central line with CVP and continuous ScvO2 monitoring

Interventions

Esophageal Doppler monitoring - CardioQ, Deltex Inc DEVICE

6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM

MiCHO

Central line with CVP and continuous ScvO2 monitoring DEVICE

6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

EGDT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• University of Massachusetts, Worcester: collaborator
• Wayne State University: collaborator
• VA Loma Linda Health Care System: collaborator

Study Sites (4)

Loma Linda University

Loma Linda, California, 92354, United States

Location

VA Loma Linda Health Care System

Loma Linda, California, 92357, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (4)

• 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.

  PMID: 11794169 BACKGROUND

• 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.

  PMID: 15242867 BACKGROUND

• 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.

  PMID: 17313691 BACKGROUND

• 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.

  PMID: 16137384 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Results Point of Contact

• Title: H. Bryant Nguyen
• Organization: Loma Linda University

hbnguyen@llu.edu

909-558-4000

Study Officials

• H. Bryant Nguyen, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 25, 2014
• Results First Posted: June 25, 2014

Record last verified: 2014-05

Locations

US (4)