Covid19CORDEALNCT04743232
COVID-19 Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
A study testing Decision tool for clinicians in people with Covid19 and Cardiac Arrest, run by Erasmus Medical Center at 7 sites in Netherlands.
Trial summary
During the Corona Virus Pandemic health care resources have become scare, and the pandemic has brought forth the need for risk stratification of patients suffering from COVID19 in order to allocate resources appropriately. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Cardiac Arrest
- What is being tested?
- Decision tool for clinicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesNetherlands
- Study dates
- 1 Mar 2021to 31 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)
Who cannot join
- minors
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
OLVG
Amsterdam, North Holland, 1091AC
Amsterdam UMC
Amsterdam
Rijnstate
Arnhem
Medisch Spectrum Twente
Enschede
Radboud UMC
Nijmegen
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079DZ
Erasmus MC
Rotterdam, 3015CE
About this study
Official title: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) or COVID-19 Pandemic Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
During the Corona Virus Pandemic health care resources have become scare, and the pandemic has brought forth the need for risk stratification of patients suffering from COVID19 in order to allocate resources appropriately. One of scarcest resources is Intensive Care treatment, mostly related to the need for invasive ventilation or for (post) cardiac arrest care.
To identify patients for whom ICU-treatment is most successful and those for whom it would be futile, would allow for installing appropriate advanced care directives for escalation or limitation of treatment.
Read the detailed description
Disease resulting from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a high mortality rate with deaths predominantly caused by respiratory failure. As of 1 September 2020, over 25 million people had confirmed coronavirus disease 2019 (COVID-19) worldwide and at least 850 000 people had died from the disease. As hospitals around the world are faced with an influx of patients with COVID-19, there is an urgent need for a pragmatic risk stratification tool that will allow the early identification of patients infected with SARS-CoV-2 who are at the highest risk of death to guide management and optimise resource allocation.
As is apparent not only from medical literature, but also from popular media, there is a need for risk stratification and decision aid. The problem with our current health care capacity mainly pertains to ICU-admissions. Ideally, clinicians would be able to predict who benefits from invasive ICU-treatment, and who does not. Subsequently, patients for whom ICU-admission is futile,doctors can install advanced care directives to refrain from escalation and limit the curative treatment they receive, and rather focus on palliation. As the investigators of this study previously discovered, patients are not unwilling to discuss these matters. In COVID-19 patients, three interventions seem logical to warrant special attention: ICU-admission, invasive ventilatory support and cardiopulmonary resuscitation. The latter because mortality in cardiac arrest patients with concurrent COVID appears higher than in non-COVID patients and performing CPR in patients with contagious diseases can potentially bring harm to health care providers.
Prognostic scores attempt to transform complex clinical pictures into tangible numerical values.
Dutch clinicians in general have been particularly busy identifying and providing prognostic scores for mortality and ICU-admission. Recent reviews listed many prognostic scores used for COVID-19, which varied in their setting, predicted outcome measure, and the clinical parameters included. It also highlights the importance of age, something that has been a subject to political debate. Therefore, in the past months, two Dutch research groups and one British group have developed two prognostic scores:
- COVID Outcome Prediction in the Emergency department: COPE (ErasmusMC, NL)
- Risk Stratification in the Emergency Department in Acutely Ill Older Patient:
RISE-UP (MUMC+, NL) 3. The International Severe Acute Respiratory and emerging Infections Consortium Coronavirus Clinical Characterisation Consortium of the World Health Organisation: 4C-score (UK)
In non-COVID patients, the Good Outcome for Attempted Resuscitation (GO-FAR) score serves as an acceptable prognostic tool for the prognosis of Cardiopulmonary Resuscitation (CPR). To date, no prognostic tool has been developed for CPR in COVID-patients. Last April, the Dutch board of intensive care medicine (NVIC) wrote a handbook to guide clinicians during the phase of the pandemic where resources would be limited to none (Code Black). In this handbook they summed up criteria in patients for whom ICU-admission would be futile or not-recommendable. Among these criteria was cardiac arrest. These criteria have however never been researched. Furthermore, although this handbook is necessary, there is no guidance for installing advanced care directives in the current stage of the pandemic, i.e. situations which are not Code Black - situations.
The aim of this study is to implement a clinical decision tool to aid clinicians in establishing advanced care directives about escalation and limitation of treatment in COVID-patients. The decision tool will provide two novelties: 1) A structured approach to discussing advanced care directives with patients who need to be admitted to hospital, and 2) A comprehensive oversight of available risk scores. The decision tool will not provide cut-off values or dichotomous decisions, this will be left to the discretion of the responsible physician. The secondary goal is to evaluate the use of this decision tool in terms of ICU-admissions, mortality and health care professionals' satisfaction with the implemented decision tool.
- Conditions
- Covid19, Cardiac Arrest
- Being tested
- Decision tool for clinicians
- Medical subject headings
- COVID-19, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision tool for cliniciansOther
Clinical decision aid, using a structured approach to advanced care directives and a comprehensive view of available risk scores.
| Study group | Role | What they receive |
|---|---|---|
| Standard practice | No intervention | Standard practice concerning advanced care directives; care as usual |
| Decision aid implementation | Experimental | Stepped-wedge implementation of the intervention Receives: Other: Decision tool for clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-admissions
number of ICU-admissions at baseline and after implementation of the intervention
Measured: before and after the intervention; total duration is 12 weeks.
Secondary outcomes (3)
Mortality
COVID mortality rates for hospital, ICU-mortality, 30-day and 1-year mortality.
Measured: before and after the intervention; patient follow-up at 30 days and 1 year
Health care professionals' satisfaction
Health care professionals' satisfaction with the implemented decision tool and with the decision process as a whole. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Measured: Measurements are repeated, before and after the intervention; total duration is 12 weeks.
Patient satisfaction
Patient satisfaction with the the communication in the hospital. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Measured: Measurement is only done once. In one group of patients before and another group after the intervention; total duration is 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Jan 2025 (estimated)
Why it stopped: Because the COVID pandemic became less severe (omikron)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Schluep, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743232
- Sponsor's protocol ID
- NL76435
- Acronym
- CORDEAL
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) or COVID-19 Pandemic Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
- ClinicalTrials.gov ID
- NCT04743232
- Acronym / sponsor ID
- CORDEAL / NL76435
- Conditions
- Covid19, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because the COVID pandemic became less severe (omikron)
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- 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.
During the Corona Virus Pandemic health care resources have become scare, and the pandemic has brought forth the need for risk stratification of patients suffering from COVID19 in order to allocate resources appropriately. One of scarcest resources is Intensive Care treatment, mostly related to the need for invasive ventilation or for (post) cardiac arrest care.
To identify patients for whom ICU-treatment is most successful and those for whom it would be futile, would allow for installing appropriate advanced care directives for escalation or limitation of treatment.
Detailed description
Disease resulting from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a high mortality rate with deaths predominantly caused by respiratory failure. As of 1 September 2020, over 25 million people had confirmed coronavirus disease 2019 (COVID-19) worldwide and at least 850 000 people had died from the disease. As hospitals around the world are faced with an influx of patients with COVID-19, there is an urgent need for a pragmatic risk stratification tool that will allow the early identification of patients infected with SARS-CoV-2 who are at the highest risk of death to guide management and optimise resource allocation.
As is apparent not only from medical literature, but also from popular media, there is a need for risk stratification and decision aid. The problem with our current health care capacity mainly pertains to ICU-admissions. Ideally, clinicians would be able to predict who benefits from invasive ICU-treatment, and who does not. Subsequently, patients for whom ICU-admission is futile,doctors can install advanced care directives to refrain from escalation and limit the curative treatment they receive, and rather focus on palliation. As the investigators of this study previously discovered, patients are not unwilling to discuss these matters. In COVID-19 patients, three interventions seem logical to warrant special attention: ICU-admission, invasive ventilatory support and cardiopulmonary resuscitation. The latter because mortality in cardiac arrest patients with concurrent COVID appears higher than in non-COVID patients and performing CPR in patients with contagious diseases can potentially bring harm to health care providers.
Prognostic scores attempt to transform complex clinical pictures into tangible numerical values.
Dutch clinicians in general have been particularly busy identifying and providing prognostic scores for mortality and ICU-admission. Recent reviews listed many prognostic scores used for COVID-19, which varied in their setting, predicted outcome measure, and the clinical parameters included. It also highlights the importance of age, something that has been a subject to political debate. Therefore, in the past months, two Dutch research groups and one British group have developed two prognostic scores:
- COVID Outcome Prediction in the Emergency department: COPE (ErasmusMC, NL)
- Risk Stratification in the Emergency Department in Acutely Ill Older Patient:
RISE-UP (MUMC+, NL) 3. The International Severe Acute Respiratory and emerging Infections Consortium Coronavirus Clinical Characterisation Consortium of the World Health Organisation: 4C-score (UK)
In non-COVID patients, the Good Outcome for Attempted Resuscitation (GO-FAR) score serves as an acceptable prognostic tool for the prognosis of Cardiopulmonary Resuscitation (CPR). To date, no prognostic tool has been developed for CPR in COVID-patients. Last April, the Dutch board of intensive care medicine (NVIC) wrote a handbook to guide clinicians during the phase of the pandemic where resources would be limited to none (Code Black). In this handbook they summed up criteria in patients for whom ICU-admission would be futile or not-recommendable. Among these criteria was cardiac arrest. These criteria have however never been researched. Furthermore, although this handbook is necessary, there is no guidance for installing advanced care directives in the current stage of the pandemic, i.e. situations which are not Code Black - situations.
The aim of this study is to implement a clinical decision tool to aid clinicians in establishing advanced care directives about escalation and limitation of treatment in COVID-patients. The decision tool will provide two novelties: 1) A structured approach to discussing advanced care directives with patients who need to be admitted to hospital, and 2) A comprehensive oversight of available risk scores. The decision tool will not provide cut-off values or dichotomous decisions, this will be left to the discretion of the responsible physician. The secondary goal is to evaluate the use of this decision tool in terms of ICU-admissions, mortality and health care professionals' satisfaction with the implemented decision tool.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standard practice | No intervention | –Standard practice concerning advanced care directives; care as usual |
| Decision aid implementation | Experimental | Other: Decision tool for cliniciansStepped-wedge implementation of the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)
Key exclusion criteria (1 listed)
- minors
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 |
|---|---|---|
| Decision tool for cliniciansClinical decision aid, using a structured approach to advanced care directives and a comprehensive view of available risk scores. | Other | Decision aid implementation |
Primary outcome
ICU-admissions
Time frame: before and after the intervention; total duration is 12 weeks.
number of ICU-admissions at baseline and after implementation of the intervention
3 secondary outcomes
Mortality
Time frame: before and after the intervention; patient follow-up at 30 days and 1 year
Health care professionals' satisfaction
Time frame: Measurements are repeated, before and after the intervention; total duration is 12 weeks.
Patient satisfaction
Time frame: Measurement is only done once. In one group of patients before and another group after the intervention; total duration is 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision tool for clinicians in people with Covid19 and Cardiac Arrest, run by Erasmus Medical Center at 7 sites in Netherlands.
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 1 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: paused, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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?
Results are not available in the source record.
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?
ICU-admissions (time frame: before and after the intervention; total duration is 12 weeks.). 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 15 Feb 2023.