Diagnostic Investigation and Prediction of Shock

NCT ID: NCT03043170

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 361 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-08-31

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

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.

Conditions

Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound Cardiac Output Monitor

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

Intervention Type: DEVICE

Other Intervention Names

USCOM®; USCOM Pty Ltd, NSW, Australia

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• <18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiff University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy H Rainer, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Emergency Medicine

Locations

Cardiff University

Cardiff, S Glamorgan, United Kingdom

Countries

United Kingdom

Other Identifiers

CardiffU

Identifier Type: -

Identifier Source: org_study_id