Inferior Vena Cava Collapsibility Index in Severe Sepsis

July 21, 2014 updated by: Simon Richards, Teesside University

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

Unknown

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

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West yorkshire
      • Leeds, West yorkshire, United Kingdom, LS9 7TF
        • St James'S University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Teesside University

Investigators

  • Principal Investigator: Simon Richards, MHSc, Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

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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