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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04445259
Other study ID # 283672
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2020
Est. completion date December 31, 2022

Study information

Verified date August 2021
Source Guy's and St Thomas' NHS Foundation Trust
Contact Marlies Ostermann, MD, PhD
Phone 0044 207 188 3038
Email Marlies.Ostermann@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United Kingdom Guy's & St Thomas' Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust Harvard Medical School

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of any stage of acute kidney injury As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria 14 days
Secondary Mortality Mortality 14-day, hospital, and intensive care unit (ICU) mortality
Secondary Renal recovery Defined by return of creatinine to < 1.5 times of baseline 14 days
Secondary Percentage of patients who receive renal replacement therapy Percentage 14 days
Secondary Percentage of participants who are dialysis dependent Percentage of participants who are dialysis dependent Through study completion, an average of 90 days
Secondary Free-days of vasoactive medications and mechanical ventilation Days without vasoactive medications and mechanical ventilation Day 30
Secondary Length of intensive care unit and hospital stay Length of intensive care unit and hospital stay Through study completion, an average of 90 days
Secondary Number of participants with consequences following AKI Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia Through study completion, an average of 90 days
Secondary Time from illness onset to need for mechanical ventilator support Time from illness onset to need for mechanical ventilator support Through study completion, an average of 30 days
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