ShockDiPSNCT03043170
Diagnostic Investigation and Prediction of Shock
An observational study of Shock, run by Cardiff University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Ultrasound Cardiac Output Monitor
- Type of treatment
- Medical device
- How many people
- 361 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adult patients aged ≥18 years
- a NEWS≥3,
- requiring a trolley
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Investigation and Prediction of Shock (The DiPS Study)
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.
Read more
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:
- What is the probability that a patient has shock?
- What type of shock does the patient have?
We propose:
- To investigate whether advanced haemodynamic variables using USCOM predict 7-day mortality and ICU admission.
- To investigate whether advanced haemodynamic variables using USCOM improve the detection and classification of shock.
- To validate and refine Li's a priori Pragmatic Shock (LiPS) method for detecting and classifying shock.
- To evaluate clinical experience for shock.
- 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
- Being tested
- Ultrasound Cardiac Output Monitor
- Keywords
- Adults, Emergency Department, Haemodynamics, Resuscitation, Shock, Uscom
- Medical subject headings
- Shock, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Cardiac Output MonitorDevice
Also called USCOM®; USCOM Pty Ltd, NSW, Australia
a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of ICCU/all cause mortality
Number of patients with admission to either ICU, or CCU, or death from any cause
Measured: 7 days
Secondary outcomes (5)
In-hospital mortality
Number of patients with death from any cause in hospital
Measured: 28 days
28-day mortality
Number of patients with death from any cause within 28 days
Measured: 28 days
Admission to ICCU
Number of patients with admission to either ICU or CCU
Measured: 7 days
ED shock
Number of patients with shock in the ED defined according to LiPS criteria
Measured: 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.
Measured: Within 4 hours of ED arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy H Rainer, MD, Principal investigator, Professor of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043170
- Sponsor's protocol ID
- CardiffU
- Acronym
- DiPS
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Investigation and Prediction of Shock (The DiPS Study)
- ClinicalTrials.gov ID
- NCT03043170
- Acronym / sponsor ID
- DiPS / CardiffU
- Conditions
- Shock
- Keywords
- Adults, Emergency Department, Haemodynamics, Resuscitation, Shock, Uscom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the probability that a patient has shock?
- What type of shock does the patient have?
We propose:
- To investigate whether advanced haemodynamic variables using USCOM predict 7-day mortality and ICU admission.
- To investigate whether advanced haemodynamic variables using USCOM improve the detection and classification of shock.
- To validate and refine Li's a priori Pragmatic Shock (LiPS) method for detecting and classifying shock.
- To evaluate clinical experience for shock.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years
- a NEWS≥3,
- requiring a trolley
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Cardiac Output MonitorAlso: USCOM®; USCOM Pty Ltd, NSW, Australiaa device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound | Device | – |
Primary outcome
Composite of ICCU/all cause mortality
Time frame: 7 days
Number of patients with admission to either ICU, or CCU, or death from any cause
5 secondary outcomes
In-hospital mortality
Time frame: 28 days
28-day mortality
Time frame: 28 days
Admission to ICCU
Time frame: 7 days
ED shock
Time frame: Within 4 hours of ED arrival
Types of ED Shock
Time frame: Within 4 hours of ED arrival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided. No plan
Related trials for Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy H Rainer, MD principal investigator
Professor of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of ICCU/all cause mortality (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.