Inferior Vena Cava Collapsibility Index in Severe Sepsis

NCT ID: NCT02195830

Last Updated: 2014-07-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Sepsis Severe Sepsis Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type OTHER

Ultrasound of the inferior vena cava

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teesside University

OTHER

Sponsor Role lead

Responsible Party

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Simon Richards

Programme Leader Medical Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

Central Contacts

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Simon Richards, MHSc

Role: CONTACT

Facility Contacts

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Stuart M Nuttall, FCEM

Role: primary

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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