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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445259
• Other study ID #: 283672
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID
• Critical Illness
• Wounds and Injuries

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