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

• Sponsor: Loma Linda University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00535821
• Collaborator: University of Massachusetts, Worcester (Other), Wayne State University (Other), VA Loma Linda Health Care System (U.S. Fed)
• Enrollment: 5
• Locations: 4
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

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
• 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: Jun 1, 2007
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 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 [hospital]

   In-hospital mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92354
2	VA Loma Linda Health Care System	Loma Linda	California	United States	92357
3	University of Massachusetts	Worcester	Massachusetts	United States	01655
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: H. Bryant Nguyen, Medical Doctor, Loma Linda University
• ClinicalTrials.gov Identifier: NCT00535821
• Other Study ID Numbers: 57121
• First Posted: Sep 26, 2007
• Last Update Posted: Jun 25, 2014
• Last Verified: May 1, 2014

• Keywords provided by H. Bryant Nguyen, Medical Doctor, Loma Linda University: Emergency Department; Hemodynamic Optimization; Esophageal Doppler monitoring; Early Goal-Directed Therapy
• Additional relevant MeSH terms: Shock, Septic; Sepsis; Shock

Study Results

Participant Flow

Arm/Group Title	MiCHO	EGDT
Arm/Group Description	A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM	A 6-hour resuscitation protocol utilizing CVP/ScvO2 Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
Period Title: Overall Study
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	MiCHO	EGDT	Total
Arm/Group Description	A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM	A 6-hour resuscitation protocol utilizing CVP/ScvO2 Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring	Total of all reporting groups
Overall Participants	2	3	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.5 (10.5)	60.7 (1.2)	69.0 (6.1)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	3 100%	3 60%
>=65 years	2 100%	0 0%	2 40%
Sex: Female, Male (Count of Participants)
Female	0 0%	1 33.3%	1 20%
Male	2 100%	2 66.7%	4 80%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%
SBP < 90 or Lactate >= 4 mmol/L (participants) [Number]
Number [participants]	2 100%	3 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Mortality
Description	In-hospital mortality
Time Frame	hospital

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MiCHO	EGDT
Arm/Group Description	A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM	A 6-hour resuscitation protocol utilizing CVP/ScvO2 Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
Measure Participants	2	3
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	MiCHO		EGDT
Arm/Group Description	A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM		A 6-hour resuscitation protocol utilizing CVP/ScvO2 Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
All Cause Mortality
	MiCHO		EGDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MiCHO		EGDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	MiCHO		EGDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.