Inferior Vena Cava Collapsibility Index in Severe Sepsis

Sponsor

Teesside University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02195830

Collaborator

(none)

112

Enrollment

Location

Arm

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Severe Sepsis Septic Shock	Other: Ultrasound of the inferior vena cava	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean baseline inferior vena cava collapsibility index [At enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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