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

• ClinicalTrials.gov Identifier: NCT00535821
• Recruitment Status: Terminated
• First Posted: September 26, 2007
• Results First Posted: June 25, 2014
• Last Update Posted: June 25, 2014
• Sponsor: Loma Linda University
• Collaborators: University of Massachusetts, Worcester; Wayne State University; VA Loma Linda Health Care System
• Information provided by (Responsible Party): H. Bryant Nguyen, Loma Linda University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Severe Sepsis; Septic Shock	Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc; Device: Central line with CVP and continuous ScvO2 monitoring	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2007
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: MiCHO; A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)	Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc; 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
Active Comparator: EGDT; A 6-hour resuscitation protocol utilizing CVP/ScvO2	Device: Central line with CVP and continuous ScvO2 monitoring; 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: hospital ]
   In-hospital mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Loma Linda University

Loma Linda, California, United States, 92354

VA Loma Linda Health Care System

Loma Linda, California, United States, 92357

United States, Massachusetts

University of Massachusetts

Worcester, Massachusetts, United States, 01655

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Loma Linda University

University of Massachusetts, Worcester

Wayne State University

VA Loma Linda Health Care System

Investigators

• Principal Investigator: H. Bryant Nguyen, MD; Loma Linda University

More Information

Publications:

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.

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. Epub 2004 Jul 8. Erratum in: BMJ. 2004 Aug 21;329(7463):438.

Chytra I, Pradl R, Bosman R, Pelnár P, Kasal E, Zidková A. Esophageal Doppler-guided fluid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care. 2007;11(1):R24.

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. Epub 2005 May 27. Review.

• Responsible Party: H. Bryant Nguyen, Medical Doctor, Loma Linda University
• ClinicalTrials.gov Identifier: NCT00535821
• Other Study ID Numbers: 57121
• First Posted: September 26, 2007
• Results First Posted: June 25, 2014
• Last Update Posted: June 25, 2014
• Last Verified: May 2014

Keywords provided by H. Bryant Nguyen, Loma Linda University:

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

Additional relevant MeSH terms:

Shock, Septic; Sepsis; Shock; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation