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

Septic Shock Clinical Trial

— MiCHO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535821
• Other study ID #: 57121
• Status: Terminated
• Phase: Phase 4
• First received: September 24, 2007
• Last updated: May 22, 2014
• Start date: June 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic

Intervention

Device:
• Esophageal Doppler monitoring - CardioQ, Deltex Inc
6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
• Central line with CVP and continuous ScvO2 monitoring
6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	Loma Linda University	Loma Linda	California
United States	VA Loma Linda Health Care System	Loma Linda	California
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Loma Linda University	University of Massachusetts, Worcester, VA Loma Linda Health Care System, Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Epub 2005 May 27. Review. — View 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. Epub 2004 Jul 8. Erratum in: BMJ. 2004 Aug 21;329(7463):438. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	In-hospital mortality	hospital	No