ClinicalTrials.gg
CompletedNCT03043170DiPSUpdated Jan 5, 2021

Diagnostic Investigation and Prediction of Shock

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
361
Ages
18 Years and older
Sex
All
01

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
Read the detailed description

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:

  • Do Uscom-derived haemodynamic variables measured in the ED predict patients who at high risk of death, admission to ICU, and have shock?
  • Does a refined LiPS definition better predict mortality and ICU admission?
  • Do advanced haemodynamic predictors and/or refined LiPS predict better than experienced physicians the presence and classification of patients with shock, mortality and ICU admission?

This study will answer two main questions:

  1. What is the probability that a patient has shock?
  2. What type of shock does the patient have?

We propose:

  1. To investigate whether advanced haemodynamic variables using USCOM predict 7-day mortality and ICU admission.
  2. To investigate whether advanced haemodynamic variables using USCOM improve the detection and classification of shock.
  3. To validate and refine Li's a priori Pragmatic Shock (LiPS) method for detecting and classifying shock.
  4. To evaluate clinical experience for shock.
  5. To inform on the feasibility of future studies

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.

02

Conditions studied

  • Shock

Keywords

  • Adults
  • Emergency Department
  • Haemodynamics
  • Resuscitation
  • Shock
  • Uscom
03

In context

Shock

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
361 participants (actual)
Patient registry
No

Interventions

  • DeviceUltrasound Cardiac Output Monitor

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

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. In-hospital mortality

    Number of patients with death from any cause in hospital

    Time frame: 28 days

  2. 28-day mortality

    Number of patients with death from any cause within 28 days

    Time frame: 28 days

  3. Admission to ICCU

    Number of patients with admission to either ICU or CCU

    Time frame: 7 days

  4. ED shock

    Number of patients with shock in the ED defined according to LiPS criteria

    Time frame: Within 4 hours of ED arrival

  5. 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

Other outcomes

  1. 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

07

Study locations

1 site
  • Cardiff University
    Cardiff, S Glamorgan CF14 4XN, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided — No plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Feb 2, 2017
First posted
Feb 3, 2017
StartActual
Mar 1, 2017
Primary completionActual
Aug 31, 2018
CompletionActual
Aug 31, 2018
Last update
Jan 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03043170
Lead sponsor
Cardiff University
Responsible party
Sponsor
First posted
Feb 3, 2017
Start date
Mar 1, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Jan 5, 2021

Study contacts

Timothy H Rainer, MD
principal investigator · Professor of Emergency Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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