Inferior Vena Cava Collapsibility Index in Severe Sepsis
NCT ID: NCT02195830
Last Updated: 2014-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single arm - Ultrasound
All participants will have an Ultrasound measurement of their inferior vena cava at enrolment as described in the intervention
Ultrasound of the inferior vena cava
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
Interventions
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Ultrasound of the inferior vena cava
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Teesside University
OTHER
Responsible Party
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Simon Richards
Programme Leader Medical Ultrasound
Principal Investigators
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Simon Richards, MHSc
Role: PRINCIPAL_INVESTIGATOR
Teesside University
Locations
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St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14/NE/0023
Identifier Type: OTHER
Identifier Source: secondary_id
AE14/11038
Identifier Type: -
Identifier Source: org_study_id
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