SepsisCOMMITNCT01484106
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
A study testing Fluid Resuscitation in people with Sepsis, run by Cheetah Medical Inc. at 12 sites in United States.
Trial summary
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Fluid Resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with old suspected or confirmed infection
- At least two of the following four criteria (SIRS):
- Temperature > 38 or < 36o C
- Heart rate > 90 bpm
- Respiratory rate > 20 bpm or PaCO2< 32 mmHg
- White blood cell count >12,000 or <4,000 per mm3; or >10% bandemia
- Lactate ≥2.0 and ≤4.0 mMol/L
- Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
Who cannot join
- Age < 18 years
- On vasopressor therapy
- Systolic blood pressure < 90 mmHg
- Received more than 3-liter crystalloid fluid prior to randomization
- Patient presenting with pulmonary edema
- Patient presenting with acute coronary syndrome
Show all 13Show fewer
- Patient presenting with new onset cardiac arrhythmia
- Patient presenting with trauma, including burns
- Patient requires immediate surgery
- Patient presenting with stroke
- Patient with end stage renal disease on renal replacement therapy
- Patient with known pregnancy
- Patient being treated with immunosuppressive therapy for organ transplant
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama
Birmingham, Alabama, 35294
MGH
Boston, Massachusetts, 02114
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dr. Nate Shapiro
Boston, Massachusetts, 02118
NY Methodist Hospital
Brooklyn, New York, 11215
Denver Health and Hospital Authority
Denver, Colorado, 80204
Northwester University
Evanston, Illinois, 60208
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California
Sacramento, California, 95817
Humility of Mary Health Partners
Youngstown, Ohio, 98661
About this study
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.
- Conditions
- Sepsis
- Being tested
- Fluid Resuscitation, Standard of Care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid ResuscitationOther
In the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is "fluid responsive" (FR).
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms. Receives: Other: Fluid Resuscitation |
| Control | Active comparator | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
A patient will be considered to have progressive organ dysfunction if their "Sequential Organ Failure Assessment" (SOFA) score increases by ≥1 point from their baseline score within 72 hours of study enrollment.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheetah Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nate Shapiro, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484106
- Sponsor's protocol ID
- 01-CM-2011
- Acronym
- COMMIT
- Status last verified
- Jul 2021
- First submitted
- 28 Nov 2011
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
- ClinicalTrials.gov ID
- NCT01484106
- Acronym / sponsor ID
- COMMIT / 01-CM-2011
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cheetah Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Fluid ResuscitationPatients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms. |
| Control | Active comparator | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients > 18 years with old suspected or confirmed infection
- At least two of the following four criteria (SIRS):
- Lactate ≥2.0 and ≤4.0 mMol/L
- Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
Key exclusion criteria (13 listed)
- Age < 18 years
- On vasopressor therapy
- Systolic blood pressure < 90 mmHg
- Received more than 3-liter crystalloid fluid prior to randomization
- Patient presenting with pulmonary edema
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 |
|---|---|---|
| Fluid ResuscitationIn the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is "fluid responsive" (FR). | Other | Treatment group |
| Standard of CareStandard of Care | Other | Control |
Primary outcome
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
Time frame: 72 hours
A patient will be considered to have progressive organ dysfunction if their "Sequential Organ Failure Assessment" (SOFA) score increases by ≥1 point from their baseline score within 72 hours of study enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Nate Shapiro, MD principal investigator
Beth Israel Deaconess Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Resuscitation in people with Sepsis, run by Cheetah Medical Inc. at 12 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2021.