Inferior Vena Cava Collapsibility Index in Severe Sepsis

NCT02195830 | Unknown

• 2 other identifiers: AE14/1103814/NE/0023
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Severe Sepsis; Septic Shock

Keywords

Sepsis; ultrasound; inferior vena cava collapsibility

Outcome Measures

Primary Outcomes (1)

• Mean baseline inferior vena cava collapsibility index

  At enrollment

Study Arms (1)

Single arm - Ultrasound

OTHER

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

Interventions

Ultrasound of the inferior vena cava 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

Single arm - Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Teesside University: lead

Study Sites (1)

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Simon Richards, MHSc

  Teesside University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Richards, MHSc

CONTACT

s.richards@tees.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Programme Leader Medical Ultrasound

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

GB (1)