NCT03043170: DiPS

Diagnostic Investigation and Prediction of Shock

Completed Last updated 5 January 2021

What this trial tests

trial testing Ultrasound Cardiac Output Monitor in Shock in 361 participants. Completed in 31 August 2018.

Timeline

1 March 2017

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	Cardiff University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	361
Start date	1 March 2017
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Ultrasound Cardiac Output Monitor

Conditions studied

• Shock — all drugs for Shock →

Sponsor

Cardiff University

Who can join

18 and older, any sex, with Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.