Severe SepsisPhase 4MiCHONCT00535821
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
A Phase 4 study testing Esophageal Doppler monitoring - CardioQ, Deltex Inc and Central line with CVP and continuous ScvO2 monitoring in people with Severe Sepsis and Septic Shock, run by Loma Linda University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Esophageal Doppler monitoring - CardioQ, Deltex Inc and Central line with CVP and continuous ScvO2 monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Acute stroke
- Acute cardiogenic pulmonary edema
- Status asthmaticus
- Unstable cardiac dysrhythmia
- Active hemorrhage
Show all 11Show fewer
- Acute seizure
- Drug overdose
- Trauma
- Requiring immediate surgery
- Do-not-resuscitate status
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Wayne State University
Detroit, Michigan, 48201
Loma Linda University
Loma Linda, California, 92354
VA Loma Linda Health Care System
Loma Linda, California, 92357
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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
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
- Being tested
- Esophageal Doppler monitoring - CardioQ, Deltex Inc, Central line with CVP and continuous ScvO2 monitoring
- Keywords
- Emergency Department, Hemodynamic Optimization, Esophageal Doppler monitoring, Early Goal-Directed Therapy
- Medical subject headings
- Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Doppler monitoring - CardioQ, Deltex IncDevice
6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
Central line with CVP and continuous ScvO2 monitoringDevice
6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
| Study group | Role | What they receive |
|---|---|---|
| MiCHO | Experimental | A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) Receives: Device: Esophageal Doppler monitoring - CardioQ, Deltex Inc |
| EGDT | Active comparator | A 6-hour resuscitation protocol utilizing CVP/ScvO2 Receives: Device: Central line with CVP and continuous ScvO2 monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: slow enrollement unavailable technology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Wayne State University, VA Loma Linda Health Care System
- Responsible party
- Principal investigator, H. Bryant Nguyen, Loma Linda University
- Investigators
- H. Bryant Nguyen, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535821
- Sponsor's protocol ID
- 57121
- Acronym
- MiCHO
- Status last verified
- May 2014
- First submitted
- 24 Sep 2007
- Last updated
- 25 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1056/NEJMoa010307.
PubMed 11794169McKendry 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.
PubMed 15242867Chytra 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.
PubMed 17313691Gunn 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.
PubMed 16137384
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00535821
- Acronym / sponsor ID
- MiCHO / 57121
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Emergency Department, Hemodynamic Optimization, Esophageal Doppler monitoring, Early Goal-Directed Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollement unavailable technology
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Wayne State University, VA Loma Linda Health Care System
- Study start
- Jun 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiCHO | Experimental | Device: Esophageal Doppler monitoring - CardioQ, Deltex IncA 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM) |
| EGDT | Active comparator | Device: Central line with CVP and continuous ScvO2 monitoringA 6-hour resuscitation protocol utilizing CVP/ScvO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnancy
- Acute stroke
- Acute cardiogenic pulmonary edema
- Status asthmaticus
- Unstable cardiac dysrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal Doppler monitoring - CardioQ, Deltex Inc6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM | Device | MiCHO |
| Central line with CVP and continuous ScvO2 monitoring6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring | Device | EGDT |
Primary outcome
Mortality
Time frame: hospital
In-hospital mortality
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11794169Rivers 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.
- Background: PubMed 15242867McKendry 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.
- Background: PubMed 17313691Chytra 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.
- Background: PubMed 16137384Gunn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Bryant Nguyen, MD principal investigator
Loma Linda University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esophageal Doppler monitoring - CardioQ, Deltex Inc and Central line with CVP and continuous ScvO2 monitoring in people with Severe Sepsis and Septic Shock, run by Loma Linda University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535821, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.