None listed
Conditions
Brief summary
In December 2019, several cases of atypical pneumonia caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were reported in Wuhan, China. This novel virus has now become responsible for a pandemic (COVID-19). In most of cases, COVID-19 is a self-limited lower respiratory tract illness. However, in some patients, it causes acute respiratory distress syndrome (ARDS), shock, myocardial injury, acute kidney injury, and multiorgan failure develop. A significant proportion of mechanically ventilated patients with COVID-19 infection require vasopressor support. Conventional and recommended agents used for such support include norepinephrine and vasopressin. Angiotensin II may be a suitable agent in patients with COVID-19 because of its potential nephroprotective effect, its potentially ability to specifically assist in patients recently exposed to angiotensin converting enzyme inhibitors (ACEIs), and because of its potential to affect the internalization and downregulation of angiotensin converting enzyme 2 (ACE2). This is relevant to COVID-19-associated critical illness because ACE is both the protein responsible for the break-down of angiotensin II to Angiotensin 1-7 and is the receptor for the viral entry into the cells. The primary aim is to generate an international, multicentre network of integrated care for patients with COVID-19 treated with angiotensin II or other novel therapy to monitor safety and to monitor outcomes. The hypothesis is that, in patients with COVID-19 receiving angiotensin II or novel therapy, additional evidence of benefit or harm can be identified, improved and used to guide further research in the field with the implementation of an international angiotensin II registry.
Interventions
The ACES Partnership represents a novel, coordinated effort to create a high-quality, detailed, prospective registry of COVID-19 patients requiring angiotensin II or other novel therapy worldwide. All patients will be followed until hospital discharge. - Data collection The ACES Study Registry is a clinical registry designed to measure the quality of care and develop patient-centred approaches for patient with COVD-19 receiving angiotensin II or novel therapy. It will collect valuable health information during hospital admission for the purpose of ensuring excellence in care delivery in this highly specific patient group. Retrospective data Data on patients who have left the ICU or have died will be included under a waiver of consent. During this COVID-19 pandemic the investigators believe that it is not recommended to contact patients that have already left the ICU as: • It would add an extra emotional stress and burden to the patients and their family; • Their involvement in this registry is not a high risk; • It is not an interventional study; • Patients would not be able to breach isolation and return to the hospital to complete consent documents; • Postal deliveries are not functioning or are non-existent; and • In this period of world-wide high COVID-19 mortality a waiver for data collected retrospectively is warranted. Prospective data COVID-19 patients who are in ICU and require angiotensin II or a novel therapy are critically unwell and will be unconscious. Patients and families involved in this disease are under a great deal of stress and in many institutions families or decision makers will not be available due to isolation practices of those units. The Investigators believe it is vital that all patients administered angiotensin II or novel therapy (and matched patients) are included in the registry to accurately describe the population and gain a quick response to the best management of patients receiving angiotensin II or novel therapy. For these reasons the investigators believe all prospectively involved patients should also be included in the ACES registry under a waiver of consent. The data will be collected at ICU admission, daily until day 3, and ICU and hospital discharge.
Sponsors
Eligibility
Inclusion criteria
Adult patients who are diagnosed with COVID-19 and receiving angiotensin II infusion or novel therapy. Control patients will be adults who are diagnosed with COVID-19 but not receiving angiotensin II infusion and novel therapies. Angiotensin II group 1. Patients who are admitted to a participating centre; and 2. Diagnosed with COVID-19; and 3. Receive angiotensin II infusion. Control group 1. Patients who are admitted to a participating centre; and 2. Diagnosed with COVID-19; and 3. Not receive angiotensin II infusion; and 4. Receiving vasopressor infusion; and 5. Matched to a patient from the angiotensin II group by: a. Date of ICU admission (range of ± 2 days); and b. Age (range of ± 2 years); and c. Respiratory support at ICU admission (no support or only oxygen or non-invasive ventilation/high flow nasal cannula or invasive ventilation); and d. History of hypertension (yes or no); and e. Use of ACEIs or ARBs (use or not).
Exclusion criteria
Patients will be excluded if they are less than 18 years of age.