Official Title
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Brief Summary

The aim is to describe the epidemiology and determine the independent risk factors formortality and acute organ injury in AKI and to assess the impact of different treatmentstrategies on survival. This will allow the development of prevention strategies anddesign 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.

Unknown status
COVID
Acute Kidney Injury
Critical Illness
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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Guy's & St Thomas' Hospital
London, United Kingdom

Investigator: Marlies Ostermann, MD, PhD
Contact: 020 71883038
Marlies.Ostermann@gstt.nhs.uk

Contacts

Marlies Ostermann, MD, PhD
0044 207 188 3038 - 83036
Marlies.Ostermann@gstt.nhs.uk

Nuttha Lumlertgul, MD, PhD
0044 207 188 3038 - 83036
Nuttha.Lumlertgul@gstt.nhs.uk

Nuttha Lumlertgul, MD, PhD, Principal Investigator
Guy's & St Thomas' Hospital

Harvard Medical School (HMS and HSDM)
NCT Number
MeSH Terms
Acute Kidney Injury
Critical Illness
Wounds and Injuries