An observational study in Shock, sponsored by Cardiff University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Cardiff University · Observational
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:
Patients frequently present to emergency departments (EDs) with critical illness and injury. Shock is a life-threatening emergency, which requires urgent and rapid assessment, diagnosis and treatment, and can be classified into distributive-septic (62%), distributive-non-septic (4%), hypovolaemic (16%), cardiogenic (16%) and obstructive (2%). Sepsis is the leading cause of in-hospital death, and approximately 80% of these patients are admitted through the ED. In Chinese patients presenting to an ED in Hong Kong we have previously derived and validated a simple, a priori, pragmatic, quantitative method for recognising and classifying shock - Li's Practical Shock (LiPS) tool. This method has been validated against ICU admission and early mortality. However, it was derived in a single population in a single centre, and requires further validation and refined in other settings. Further, it does not sub-classify patients beyond 'normal, cold and warm shock', does not guide next steps in treatment, and the assessment of the peripheries is very subjective.
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.
There are many unanswered questions such as:
This study will answer two main questions:
We propose:
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.
The challenge is to discover a strategy that has a sensitivity >67% and specificity >72% for determining in-hospital mortality in clinically deteriorating or potentially shocked patients.
921 studies on the registry are indexed under Shock; 172 are open to participants now.
This study's enrollment of 361 is above the median of 93 across 355 observational studies indexed under Shock.
Browse Shock studies →Cardiff University is the lead sponsor of 44 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound
Also known as: USCOM®; USCOM Pty Ltd, NSW, Australia
Composite of ICCU/all cause mortality
Number of patients with admission to either ICU, or CCU, or death from any cause
Time frame: 7 days
In-hospital mortality
Number of patients with death from any cause in hospital
Time frame: 28 days
28-day mortality
Number of patients with death from any cause within 28 days
Time frame: 28 days
Admission to ICCU
Number of patients with admission to either ICU or CCU
Time frame: 7 days
ED shock
Number of patients with shock in the ED defined according to LiPS criteria
Time frame: Within 4 hours of ED arrival
Types of ED Shock
Number of patients with ED shock categorised as either primarily restrictive or hypovolaemic, or cardiogenic or obstructive shock.
Time frame: Within 4 hours of ED arrival
Feasibility variables
patient acceptance and experience, medical and nursing acceptance and experience, and evaluation of the infrastructure necessary to perform future definitive randomised controlled trials of this type in the emergency setting, to inform on sample sizes for future studies, to assess the processes and workload involved in patient recruitment, consent and reasons for non-participation, and to assess the potential loss to follow up and impact on analysis and interpretation
Time frame: 4 hours
Plan to share: Undecided — No plan
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Aug 2018, 17 months.
Of 175 non-industry observational studies under Shock, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 17 months is below that.
Counting every sponsor, half of 183 studies reached it within 27 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Cardiff University