Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04445259|
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
|Condition or disease|
|COVID Acute Kidney Injury Critical Illness|
Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China, over 1 million people have been infected and over 55,000 have died worldwide, and these numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from the medical research community, including translational studies to understand the pathogenesis of disease, randomized controlled trials of novel and re-purposed pharmacotherapies, and rigorously conducted epidemiologic studies that include granular patient-level data.
Current knowledge of the clinical features and outcomes of COVID-19 is mostly limited to studies from China and Italy. In one of the larger such studies, which consisted of 1099 patients hospitalized in mainland China, only 173 (16%) were classified as having severe disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine independent risk factors for death. A larger study consisting of 72,314 patients was recently published by the Chinese Center for Disease Control and Prevention. This nationwide registry study identified several important findings, including the striking monotonic relationship between older age and greater risk of death. Important limitations of the study, however, were lack of granular patient-level data and relatively few patients (<5% of the cohort) who were critically ill. Among critically ill patients with COVID-19, acute mortality rates have been reported to be as high as 49-62%, underscoring the importance of studying this patient population. Data from the United Kingdom (UK) suggest that >50% of critically ill patients have a degree of acute kidney injury (AKI) and >20% need renal replacement therapy (RRT). Mortality is particularly high in those who are mechanically ventilated and need RRT (>75%).
Detailed information about the risk of AKI, contributing factors and reasons for high mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the investigators plan to collect clinical data from >250 critically ill patients with COVID-19 admitted to the intensive care unit (ICU) at Guy's & St Thomas' Hospital. The investigators will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are leading a similar study across >50 sites in the United States.
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury|
|Actual Study Start Date :||June 20, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Critically Ill Patients with COVID-19
We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.
- Incidence of any stage of acute kidney injury [ Time Frame: 14 days ]As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
- Mortality [ Time Frame: 14-day, hospital, and intensive care unit (ICU) mortality ]Mortality
- Renal recovery [ Time Frame: 14 days ]Defined by return of creatinine to < 1.5 times of baseline
- Percentage of patients who receive renal replacement therapy [ Time Frame: 14 days ]Percentage
- Percentage of participants who are dialysis dependent [ Time Frame: Through study completion, an average of 90 days ]Percentage of participants who are dialysis dependent
- Free-days of vasoactive medications and mechanical ventilation [ Time Frame: Day 30 ]Days without vasoactive medications and mechanical ventilation
- Length of intensive care unit and hospital stay [ Time Frame: Through study completion, an average of 90 days ]Length of intensive care unit and hospital stay
- Number of participants with consequences following AKI [ Time Frame: Through study completion, an average of 90 days ]Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia
- Time from illness onset to need for mechanical ventilator support [ Time Frame: Through study completion, an average of 30 days ]Time from illness onset to need for mechanical ventilator support
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445259
|Contact: Marlies Ostermann, MD, PhD||0044 207 188 3038 ext 83036||Marlies.Ostermann@gstt.nhs.uk|
|Contact: Nuttha Lumlertgul, MD, PhD||0044 207 188 3038 ext 83036||Nuttha.Lumlertgul@gstt.nhs.uk|
|Guy's & St Thomas' Hospital||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Marlies Ostermann, MD, PhD 020 71883038 Marlies.Ostermann@gstt.nhs.uk|
|Principal Investigator:||Nuttha Lumlertgul, MD, PhD||Guy's & St Thomas' Hospital|