Diagnostic Investigation and Prediction of Shock

NCT03043170 | Completed

• 1 other identifier: CardiffU
• Study Type: observational
• Target: 361
• Locations: 1 country
• Sites: 1

Brief Summary

Background to the research Patients present to Emergency Departments (ED) with a spectrum of illness, many of which are life- threatening. The body has the ability to compensate in the early stages when things go wrong so that on the surface patients do not appear as sick as they really are. Under-diagnosis of severity of illness leads to under-treatment, unnecessary mortality, and unnecessary hospital costs. Earlier diagnosis and consequent treatment will result in prudent healthcare, cost-benefit and better patient outcomes. Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power and peripheral pressures gives vital clues to the hidden seriousness of illness and is a guide to better management. Few EDs in the world assess such haemodynamics. After evaluating a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if applied across EDs in Wales. However, before we can do that we need to strengthen our understanding of haemodynamics, and of relevant protocols and non-invasive devices that help us to acquire such information. Study Design After ethics and institutional approval is obtained from we will conduct a prospective, single-centre, cohort study on 354 adult patients with possible shock associated with an acute illness or injury who present to the Emergency Department of the University Hospital of Wales, and follow them up for 7 days. 354 is a credible number to confirm that the strategy works. Written consent will be obtained either from the patient or a relative wherever possible but a waiver of consent apply to patients who, because of confusion, unconsciousness or severe disability, may be unable to give consent. In these cases, consent will first be sought from a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a relative as soon as practically possible. What you hope to discover We expect to discover that:

• Uscom variables predict 7-day survival and ICU admission
• Uscom variables improve the detection and classification of shock
• The LiPS definition can be improved.
• The objective definition is better than doctors experience
• Patients have a good experience and are satisfied with care

Conditions

Shock

Keywords

Adults; Emergency Department; Haemodynamics; Resuscitation; Shock; Uscom

Outcome Measures

Primary Outcomes (1)

• Composite of ICCU/all cause mortality

  Number of patients with admission to either ICU, or CCU, or death from any cause

  7 days

Secondary Outcomes (5)

• In-hospital mortality

  28 days

• 28-day mortality

  28 days

• Admission to ICCU

  7 days

• ED shock

  Within 4 hours of ED arrival

• Types of ED Shock

  Within 4 hours of ED arrival

Other Outcomes (1)

• Feasibility variables

  4 hours

Interventions

Ultrasound Cardiac Output Monitor DEVICE

a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound

Also known as: USCOM®; USCOM Pty Ltd, NSW, Australia

Eligibility Criteria

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

Study Population

Consecutive adult patients presenting to the ED of University Hospital of Wales (UHW) with a NEWS\>3, requiring a trolley, and during research study periods

You may qualify if:

• Adult patients aged ≥18 years
• a NEWS≥3,
• requiring a trolley

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• Cardiff University: lead

Study Sites (1)

Cardiff University

Cardiff, S Glamorgan, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Shock; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Timothy H Rainer, MD

  Professor of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: March 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

GB (1)