ShockNISNCT02164851
Non-Invasive Shock: Differentiating Shock in the Emergency Department
An observational study of Shock and Infection, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this study is to compare the characteristics of echocardiography and different monitoring devices in shock patients, the relationship of device parameters to biomarkers associated with shock, and determine if these any of these add clinical utility when predicting the cause of shock. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shock, Infection, Inflammation
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2012to 1 Jan 2020
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients found to have shock and "near-shock" physiology in the emergency department.
Who may be able to join
- 18 years old
- determined to have shock physiology, which will be defined by vital sign requirements including SBP < 90 despite appropriate resuscitation (e.g 2 L of normal saline) for at least five minutes.
- Patients that do meet vital sign requirements and vasopressor initiation will also be included
Who cannot join
- patients determined to have atrial fibrillation with rapid ventricular response or supraventricular tachycardia, and the patient is discharged when the ventricular rate is corrected.
- Patients will also be excluded if found to have to alcohol withdrawal, intoxication, or psychiatric agitation without organic cause.
- Patients with SBP < 90 mm/hg who have been documented to have chronic low blood pressure and their blood pressure is at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The goal of this study is to compare the characteristics of echocardiography and different monitoring devices in shock patients, the relationship of device parameters to biomarkers associated with shock, and determine if these any of these add clinical utility when predicting the cause of shock. We will perform a prospective, observational study of patients found to have shock physiology in the ED and follow them to determine the final shock category and ultimate outcomes.
Read the detailed description
Shock is a common final pathway for many disease states, occurring when oxygen and nutrient delivery are not sufficient to maintain normal cellular function. The incidence of shock in the emergency department (ED) is approximated to be 1-3% of ED patients(1), and it carries a high mortality, ranging from 20-50% depending on the underlying cause of shock(2). Early recognition and treatment of shock significantly improves outcomes in critically ill patients(2, 3), and so the majority of efforts to this point have focused on identifying patients with shock.
The many etiologies of shock may be grouped into several broader categories: cardiogenic, distributive, hemorrhagic, hypovolemic, anaphylactic, and neurogenic. These categories cause shock through different mechanisms, but they have a significant amount of clinical overlap (4-7), making differentiating the cause of shock challenging for the emergency provider. While some overlap also exists between the treatments for these categories, several have vastly different therapeutic approaches. Since the early treatment of shock influences outcomes(2, 3, 8, 9), identifying the correct etiology to treat should logically impact outcomes as well, although this has not been studied in shock patients. However, Moore, et al., did show that physicians were only able to correctly identify the cause of hypotension in 25% of hypotensive patients in the ED, speaking to both the difficulty in diagnosing shock etiologies and the high percentage of patients with undifferentiated shock(10).
Recently, a number of different devices and biomarkers have been suggested to have clinical utility in differentiating shock and guiding resuscitation(11-13). These devices have potential to aid in the differentiation of shock.
We will conduct a prospective, observational study of patients found to have shock and "near-shock" physiology in the emergency department. We will identify patients meeting our inclusion criteria which will identify shock and "near shock" patients. Inclusion criteria will include: HR > 120, SBP < 90, or a shock index (HR/SBP) > 1 for at least five minutes. Patients that do meet vital sign requirements, but have a lactate > 4 mmol/L, will also be included.
Enrolled patients will undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), and extremity temperature device, as well as a blood draw for biomarker assessment.
- Conditions
- Shock, Infection, Inflammation
- Keywords
- shock, emergencies, inflammation, infection, pathologic process
- Medical subject headings
- Shock, Infections, Inflammation, Emergencies, Pathologic Processes
What is being measured
The primary outcome is the main question the study is designed to answer.
Deterioration
Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, mortality.
Measured: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
Secondary outcomes (1)
Mortality
In-hospital mortality.
Measured: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study start28 Nov 2012
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Shapiro, Beth Israel Deaconess Medical Center
- Investigators
- Nathan I Shapiro, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164851
- Sponsor's protocol ID
- 2013P000004
- Acronym
- NIS
- Status last verified
- Oct 2024
- First submitted
- 13 Jun 2014
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Shock: Differentiating Shock in the Emergency Department
- ClinicalTrials.gov ID
- NCT02164851
- Acronym / sponsor ID
- NIS / 2013P000004
- Conditions
- Shock, Infection, Inflammation
- Keywords
- shock, emergencies, inflammation, infection, pathologic process
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 28 Nov 2012 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Jun 2014 (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 goal of this study is to compare the characteristics of echocardiography and different monitoring devices in shock patients, the relationship of device parameters to biomarkers associated with shock, and determine if these any of these add clinical utility when predicting the cause of shock. We will perform a prospective, observational study of patients found to have shock physiology in the ED and follow them to determine the final shock category and ultimate outcomes.
Detailed description
Shock is a common final pathway for many disease states, occurring when oxygen and nutrient delivery are not sufficient to maintain normal cellular function. The incidence of shock in the emergency department (ED) is approximated to be 1-3% of ED patients(1), and it carries a high mortality, ranging from 20-50% depending on the underlying cause of shock(2). Early recognition and treatment of shock significantly improves outcomes in critically ill patients(2, 3), and so the majority of efforts to this point have focused on identifying patients with shock.
The many etiologies of shock may be grouped into several broader categories: cardiogenic, distributive, hemorrhagic, hypovolemic, anaphylactic, and neurogenic. These categories cause shock through different mechanisms, but they have a significant amount of clinical overlap (4-7), making differentiating the cause of shock challenging for the emergency provider. While some overlap also exists between the treatments for these categories, several have vastly different therapeutic approaches. Since the early treatment of shock influences outcomes(2, 3, 8, 9), identifying the correct etiology to treat should logically impact outcomes as well, although this has not been studied in shock patients. However, Moore, et al., did show that physicians were only able to correctly identify the cause of hypotension in 25% of hypotensive patients in the ED, speaking to both the difficulty in diagnosing shock etiologies and the high percentage of patients with undifferentiated shock(10).
Recently, a number of different devices and biomarkers have been suggested to have clinical utility in differentiating shock and guiding resuscitation(11-13). These devices have potential to aid in the differentiation of shock.
We will conduct a prospective, observational study of patients found to have shock and "near-shock" physiology in the emergency department. We will identify patients meeting our inclusion criteria which will identify shock and "near shock" patients. Inclusion criteria will include: HR > 120, SBP < 90, or a shock index (HR/SBP) > 1 for at least five minutes. Patients that do meet vital sign requirements, but have a lactate > 4 mmol/L, will also be included.
Enrolled patients will undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), and extremity temperature device, as well as a blood draw for biomarker assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients found to have shock and "near-shock" physiology in the emergency department.
Key inclusion criteria (3 listed)
- 18 years old
- determined to have shock physiology, which will be defined by vital sign requirements including SBP < 90 despite appropriate resuscitation (e.g 2 L of normal saline) for at least five minutes.
- Patients that do meet vital sign requirements and vasopressor initiation will also be included
Key exclusion criteria (3 listed)
- patients determined to have atrial fibrillation with rapid ventricular response or supraventricular tachycardia, and the patient is discharged when the ventricular rate is corrected.
- Patients will also be excluded if found to have to alcohol withdrawal, intoxication, or psychiatric agitation without organic cause.
- Patients with SBP < 90 mm/hg who have been documented to have chronic low blood pressure and their blood pressure is at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deterioration
Time frame: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, mortality.
1 secondary outcome
Mortality
Time frame: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
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 29 Oct 2024.
Related trials for Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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.
Nathan I Shapiro, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Infection, run by Beth Israel Deaconess Medical Center at 1 site 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 3 inclusion and 3 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Deterioration (time frame: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.). 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 29 Oct 2024.