Undifferentiated ShockNCT02164799
The Epidemiology and Approach to Differentiating Etiologies of Shock in the Emergency Department
An observational study of Undifferentiated Shock, run by Beth Israel Deaconess Medical Center.
Trial summary
The Shock Tool study is designed to improve the clinical evaluation for differentiating shock in the emergency department. The goal of this study is to evaluate and improve the accuracy of physicians differentiating causes of shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Shock
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department patients
Who may be able to join
- Age 18 years or great
- For pre-shock cohort: HR > 130, RR>24, Shock index > 1, lactate > 4.0mmol/L, SBP < 90mm/hg)
- For shock cohort: persistent blood pressure <90mm/hg after resuscitation
Who cannot join
- seizure
- isolated atrial fibrillation with discharge after rate control achieved
- discharged from the emergency department
- intoxication or withdrawal
About this study
Official title: Establishing a Tool to Increase the Accuracy of Emergency Physicians Diagnosing Etiologies of Shock
The Shock Tool study is designed to improve the clinical evaluation for differentiating shock in the emergency department. The goal of this study is to evaluate and improve the accuracy of physicians differentiating causes of shock.
Read the detailed description
Specific Aim #1: To study the epidemiology of shock in the emergency department Hypothesis 1: We will better understand shock states if we determine shock etiology among patients presenting to the emergency department in a carefully conducted observational prospective study.
Specific Aim #2: To determine the accuracy of physician diagnosis for the underlying etiology of shock.
Hypothesis 2: Physician assessment of the underlying cause of shock is challenging and often inaccurate in the early stages of care in the emergency department.
Specific Aim #3: To optimize the evidence-based approach to assist in the diagnosis of shock etiology from elements readily available when a patient demonstrates shock physiology in the Emergency Department.
Hypothesis 3: An evidenced-based, standardized approach to clinical decision making integrating elements of the history, physical exam, and early testing will improve a physician's ability to accurately differentiate etiologies of shock.
- Conditions
- Undifferentiated Shock
- Keywords
- Shock, Predicting diagnosis, Predicting adverse outcomes
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shock | Patients found to have persistent hypotension after resuscitation or vasopressor requirement | |
| Pre-shock | Patients with markedly abnormal vital signs (Heart Rate (HR)>130, Respiratory Rate (RR)>24, Shock Index >1, Lactate > 4.0mmol/L, or Systolic Blood Pressure (SBP) <90mm/hg) without shock, as defined previously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology of Shock
Each patient determined to have shock in the emergency department is given a single diagnosis by a reviewing physician after the hospital course is completed.
Measured: Retrospectively, 1 month after enrollment
Secondary outcomes (1)
In hospital mortality
Death by any cause during hospitalization
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 startNov 2012
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Henning, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164799
- Sponsor's protocol ID
- 2012P-000357
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Tool to Increase the Accuracy of Emergency Physicians Diagnosing Etiologies of Shock
- ClinicalTrials.gov ID
- NCT02164799
- Acronym / sponsor ID
- 2012P-000357
- Conditions
- Undifferentiated Shock
- Keywords
- Shock, Predicting diagnosis, Predicting adverse outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (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 Shock Tool study is designed to improve the clinical evaluation for differentiating shock in the emergency department. The goal of this study is to evaluate and improve the accuracy of physicians differentiating causes of shock.
Detailed description
Specific Aim #1: To study the epidemiology of shock in the emergency department Hypothesis 1: We will better understand shock states if we determine shock etiology among patients presenting to the emergency department in a carefully conducted observational prospective study.
Specific Aim #2: To determine the accuracy of physician diagnosis for the underlying etiology of shock.
Hypothesis 2: Physician assessment of the underlying cause of shock is challenging and often inaccurate in the early stages of care in the emergency department.
Specific Aim #3: To optimize the evidence-based approach to assist in the diagnosis of shock etiology from elements readily available when a patient demonstrates shock physiology in the Emergency Department.
Hypothesis 3: An evidenced-based, standardized approach to clinical decision making integrating elements of the history, physical exam, and early testing will improve a physician's ability to accurately differentiate etiologies of shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock | – | –Patients found to have persistent hypotension after resuscitation or vasopressor requirement |
| Pre-shock | – | –Patients with markedly abnormal vital signs (Heart Rate (HR)>130, Respiratory Rate (RR)>24, Shock Index >1, Lactate > 4.0mmol/L, or Systolic Blood Pressure (SBP) <90mm/hg) without shock, as defined previously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department patients
Key inclusion criteria (3 listed)
- Age 18 years or great
- For pre-shock cohort: HR > 130, RR>24, Shock index > 1, lactate > 4.0mmol/L, SBP < 90mm/hg)
- For shock cohort: persistent blood pressure <90mm/hg after resuscitation
Key exclusion criteria (4 listed)
- seizure
- isolated atrial fibrillation with discharge after rate control achieved
- discharged from the emergency department
- intoxication or withdrawal
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
Etiology of Shock
Time frame: Retrospectively, 1 month after enrollment
Each patient determined to have shock in the emergency department is given a single diagnosis by a reviewing physician after the hospital course is completed.
1 secondary outcome
In hospital 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 17 Jun 2014.
Related trials for Undifferentiated Shock
Not yet recruiting
Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
Validation of Minute Bundle in Undifferntiated 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentiated Shock, run by Beth Israel Deaconess Medical Center.
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 4 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Etiology of Shock (time frame: Retrospectively, 1 month after enrollment). 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 17 Jun 2014.