Clinical trial NCT04445259: Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Official title: Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Acute Kidney Injury
Critical Illness
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2020-06-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients with confirmed diagnosis of COVID-19

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adults (aged ≥18 years)
2. Confirmed diagnosis of COVID-19
3. Hospitalized in the ICU for illness related to COVID-19
4. Any of the following:

   * Current in-patient in ICU
   * Previous in-patient in ICU and died in ICU or hospital
   * Previous in-patient in ICU and discharged from ICU alive

Exclusion Criteria:

1. Younger than 18 years old
2. On chronic dialysis within the last year or on dialysis at ICU admission
3. Functioning kidney transplant
4. No creatinine within 48 hours of ICU admission

Primary outcomes:
measure: Incidence of any stage of acute kidney injury
timeFrame: 14 days
Secondary outcomes:
measure: Mortality
timeFrame: 14-day, hospital, and intensive care unit (ICU) mortality
measure: Renal recovery
timeFrame: 14 days
measure: Percentage of patients who receive renal replacement therapy
timeFrame: 14 days
measure: Percentage of participants who are dialysis dependent
timeFrame: Through study completion, an average of 90 days
measure: Free-days of vasoactive medications and mechanical ventilation
timeFrame: Day 30
measure: Length of intensive care unit and hospital stay
timeFrame: Through study completion, an average of 90 days
measure: Number of participants with consequences following AKI
timeFrame: Through study completion, an average of 90 days
measure: Time from illness onset to need for mechanical ventilator support
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' Hospital
Study officials:
affiliation: Guy's & St Thomas' Hospital
name: Nuttha Lumlertgul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lumlertgul N, Pirondini L, Cooney E, Kok W, Gregson J, Camporota L, Lane K, Leach R, Ostermann M. Acute kidney injury prevalence, progression and long-term outcomes in critically ill patients with COVID-19: a cohort study. Ann Intensive Care. 2021 Aug 6;11(1):123. doi: 10.1186/s13613-021-00914-5.