SepsisNCT02195830
Inferior Vena Cava Collapsibility Index in Severe Sepsis
A study testing Ultrasound of the inferior vena cava in people with Sepsis and Severe Sepsis, run by Teesside University at 1 site in United Kingdom.
Trial summary
There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis. To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- Ultrasound of the inferior vena cava
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Jul 2015
- 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
- signs and symptoms of infection with 2 or more SIRS criteria (pulse rate >90/min, Temp > 38 Celsius < 36 Celsius, Respiratory rate > 20 breaths per minute, or white cell count >12 or <4 x 10^9/L)
Who cannot join
- in relation to this episode of care: Prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.
- Patients who have received more than 20ml/Kg of IV fluid in the pre hospital environment
- Patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension
- Patients receiving palliative terminal supportive care
Trial locations and contacts
1 site in 1 country.
Simon Richards, MHSc contact
United Kingdom1 site
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Stuart M Nuttall, FCEM, stuart.nuttall@leedsth.nhs.uk
Stuart M Nuttall, FCEM
About this study
Official title: Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock
There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis.
To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients.
The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.
Read the detailed description
The study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital Emergency Department.
Eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the IVCCI will be calculated at enrolment.
Care will be provided in line with the published guidelines on sepsis management from the Surviving Sepsis Campaign and the College of Emergency Medicine.
A sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- Ultrasound of the inferior vena cava
- Keywords
- Sepsis, ultrasound, inferior vena cava collapsibility
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the inferior vena cavaOther
B mode ultrasound of the inferior vena cava Measurements taken 2cm from the hepatic vein IVC junction or 3cm from the right atrium IVC junction
| Study group | Role | What they receive |
|---|---|---|
| Single arm - Ultrasound | Other | All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention Receives: Other: Ultrasound of the inferior vena cava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean baseline inferior vena cava collapsibility index
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Richards, Teesside University
- Investigators
- Simon Richards, MHSc, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195830
- Sponsor's protocol ID
- AE14/11038
- Other IDs
- 14/NE/0023
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT02195830
- Acronym / sponsor ID
- AE14/11038
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Keywords
- Sepsis, ultrasound, inferior vena cava collapsibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 21 Jul 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.
There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis.
To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients.
The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.
Detailed description
The study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital Emergency Department.
Eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the IVCCI will be calculated at enrolment.
Care will be provided in line with the published guidelines on sepsis management from the Surviving Sepsis Campaign and the College of Emergency Medicine.
A sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm - Ultrasound | Other | Other: Ultrasound of the inferior vena cavaAll participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients
- signs and symptoms of infection with 2 or more SIRS criteria (pulse rate >90/min, Temp > 38 Celsius < 36 Celsius, Respiratory rate > 20 breaths per minute, or white cell count >12 or <4 x 10^9/L)
Key exclusion criteria (4 listed)
- in relation to this episode of care: Prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.
- Patients who have received more than 20ml/Kg of IV fluid in the pre hospital environment
- Patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension
- Patients receiving palliative terminal supportive care
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 |
|---|---|---|
| Ultrasound of the inferior vena cavaB mode ultrasound of the inferior vena cava Measurements taken 2cm from the hepatic vein IVC junction or 3cm from the right atrium IVC junction | Other | Single arm - Ultrasound |
Primary outcome
Mean baseline inferior vena cava collapsibility index
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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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.
Simon Richards, MHSc contact
Simon Richards, MHSc principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the inferior vena cava in people with Sepsis and Severe Sepsis, run by Teesside University at 1 site in United Kingdom.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 2014. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Richards, MHSc (s.richards@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean baseline inferior vena cava collapsibility index (time frame: At 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 22 Jul 2014.