Back to resultsInferior Vena Cava Collapsibility Index in Severe Sepsis
Primary Purpose
Sepsis, Severe Sepsis, Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound of the inferior vena cava
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring Sepsis, ultrasound, inferior vena cava collapsibility
Eligibility Criteria
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
Sites / Locations
- St James's University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm - Ultrasound
Arm Description
All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention
Outcomes
Primary Outcome Measures
Mean baseline inferior vena cava collapsibility index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02195830
Brief Title
Inferior Vena Cava Collapsibility Index in Severe Sepsis
Official Title
Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teesside University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe Sepsis, Septic Shock
Keywords
Sepsis, ultrasound, inferior vena cava collapsibility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm - Ultrasound
Arm Type
Other
Arm Description
All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention
Intervention Type
Other
Intervention Name(s)
Ultrasound of the inferior vena cava
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean baseline inferior vena cava collapsibility index
Time Frame
At enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Richards, MHSc
Email
s.richards@tees.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Richards, MHSc
Organizational Affiliation
Teesside University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St James's University Hospital
City
Leeds
State/Province
West yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart M Nuttall, FCEM
Email
stuart.nuttall@leedsth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Stuart M Nuttall, FCEM
12. IPD Sharing Statement
Learn more about this trial
Inferior Vena Cava Collapsibility Index in Severe Sepsis
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