Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04743232 |
| Other study ID # |
NL76435 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
January 31, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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:
1. COVID Outcome Prediction in the Emergency department:
COPE (ErasmusMC, NL)
2. 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.
