SepsisNCT02170233
SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography
An observational study of Sepsis, run by Yale University at 1 site in United States.
Trial summary
The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for severe sepsis or septic shock during their emergency department visit. A number of healthy patients will also be enrolled to act as controls for this study.
Who may be able to join
- All patients age greater than 18 years who meet criteria of sepsis. Septic shock will be defined as those patients with severe sepsis and persistent hypotension (<90mmHg systolic blood pressure) despite a fluid challenge of at least 20cc/kg
- Patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial US is performed
- A number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. These patients will only have one ultrasound performed for each of the desired study measures.
Who cannot join
- Patients unable to provide consent such as non-English speaking patients or patient/health care proxy unable to give consent
- History of significant trauma
- Incarcerated patients
- Failure to complete fluid challenge
- Pericardial disease or heart transplant. Patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (Ejection Fraction <40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.
Read the detailed description
After each 1 Liter fluid challenge of IV fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| Sepsis | This group will contain patients meeting criteria for sepsis for enrollment in the study (target population). | |
| Normals | This group will be healthy patients who will have data points recorded for controls for the study to assess the reliability of these measures on healthy patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid
Ultrasound Measurement:
Carotid corrected flow time in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Secondary outcomes (7)
Fluid volume measurement as measured by ultrasound
Ultrasound Measurement:
IVC diameter in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Early (E') septal left ventricular filling velocity as measured by ultrasound
Ultrasound Measurement:
Early (E') septal left ventricular filling velocity by tissue Doppler in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Late (A') septal left ventricular filling velocity as measured by ultrasound
Ultrasound Measure:
Late (A') septal left ventricular filling velocity by Tissue Doppler in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.
Ultrasound Measure:
Respirophasic carotid velocity (ΔVpeak) in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Ultrasound Measurement:
Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Ultrasound Measurement:
Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Ultrasound Measurement:
Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness.
Measured: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
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.
- More trials run by Yale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Moore, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170233
- Sponsor's protocol ID
- 1406014123
- Status last verified
- Jan 2020
- First submitted
- 16 Jun 2014
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography
- ClinicalTrials.gov ID
- NCT02170233
- Acronym / sponsor ID
- 1406014123
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 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 study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.
Detailed description
After each 1 Liter fluid challenge of IV fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –This group will contain patients meeting criteria for sepsis for enrollment in the study (target population). |
| Normals | – | –This group will be healthy patients who will have data points recorded for controls for the study to assess the reliability of these measures on healthy patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for severe sepsis or septic shock during their emergency department visit. A number of healthy patients will also be enrolled to act as controls for this study.
Key inclusion criteria (3 listed)
- All patients age greater than 18 years who meet criteria of sepsis. Septic shock will be defined as those patients with severe sepsis and persistent hypotension (<90mmHg systolic blood pressure) despite a fluid challenge of at least 20cc/kg
- Patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial US is performed
- A number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. These patients will only have one ultrasound performed for each of the desired study measures.
Key exclusion criteria (5 listed)
- Patients unable to provide consent such as non-English speaking patients or patient/health care proxy unable to give consent
- History of significant trauma
- Incarcerated patients
- Failure to complete fluid challenge
- Pericardial disease or heart transplant. Patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (Ejection Fraction <40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately
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
Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Ultrasound Measurement: Carotid corrected flow time in relation to cardiac output to assess fluid responsiveness.
7 secondary outcomes
Fluid volume measurement as measured by ultrasound
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Early (E') septal left ventricular filling velocity as measured by ultrasound
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Late (A') septal left ventricular filling velocity as measured by ultrasound
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.
Time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
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 13 Jan 2020.
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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.
Chris Moore, MD principal investigator
Yale University
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 Sepsis, run by Yale University 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 5 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 13 Jan 2020. 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?
Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid (time frame: participants will be followed for the duration of their emergency department stay, an expected average of 6 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 13 Jan 2020.