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Diagnostic Investigation and Prediction of Shock

NCT03043170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 361

Last updated 2021-01-05

No results posted yet for this study

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

Interventions

DEVICE

Ultrasound Cardiac Output Monitor

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

Sponsors & Collaborators

  • Cardiff University

    lead OTHER

Principal Investigators

  • Timothy H Rainer, MD · Professor of Emergency Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043170 on ClinicalTrials.gov