Inferior Vena Cava Collapsibility Index in Severe Sepsis

Sepsis Clinical Trial

Official title:

Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02195830
• Other study ID #: AE14/11038
• Secondary ID: 14/NE/0023
• Status: Not yet recruiting
• Phase: N/A
• First received: July 17, 2014
• Last updated: July 21, 2014
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: Teesside University
• Contact: Simon Richards, MHSc
• Email: s.richards[@]tees.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	St James's University Hospital	Leeds	West yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean baseline inferior vena cava collapsibility index		At enrollment	No