- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02195830
Inferior Vena Cava Collapsibility Index in Severe Sepsis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simon Richards, MHSc
- Email: s.richards@tees.ac.uk
Study Locations
-
-
West yorkshire
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Leeds, West yorkshire, United Kingdom, LS9 7TF
- St James's University Hospital
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Contact:
- Stuart M Nuttall, FCEM
- Email: stuart.nuttall@leedsth.nhs.uk
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Principal Investigator:
- Stuart M Nuttall, FCEM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm - Ultrasound
All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean baseline inferior vena cava collapsibility index
Time Frame: At enrollment
|
At enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Richards, MHSc, Teesside University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AE14/11038
- 14/NE/0023 (Other Identifier: Newcastle and North Tyneside 2 NRES committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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