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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-20

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

NCT04459975

on Occurrence of Acurate Kidney Injury During Intensive Care Unit Abnormalities of Urinary Analysis

UNKNOWN

Identification of Patients at Risk of CKD After AKI

NCT05740709

Acute Kidney Injury Kidney Diseases

RECRUITING

Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT

NCT02470520

Acute Kidney Failure

COMPLETED

Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

NCT02897310

Critical Illness Acute Kidney Injury

COMPLETED

Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

NCT04491227

Covid19 AKI CKD +2 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID Acute Kidney Injury Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Critically Ill Patients with COVID-19

We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No