Clinical trial NCT04491227: Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
Official title: Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
AKI
CKD
ESRD
Transplant;Failure,Kidney
Keywords: AKI
dialysis
CKD
COVID19
renal transplant
mortality
renal recovery
resource utilization
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed COVID 19 infection with acute and chronic kidney dysfunction.

Patients testing positive for COVID19 who meet criteria for AKI, have known CKD (with baseline eGFR less than 60), are ESKD on dialysis or kidney transplant recipients will be enrolled in the study.

Brief summary: The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions.

In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.

Detailed description: Acute and Chronic kidney diseases are important causes of mortality and morbidity worldwide. The associated socioeconomic burden of kidney disease and AKI, as in some cases recovery is incomplete and chronic kidney disease (CKD) can arise, is a growing problem around the world. During the COVID 19 pandemic the incidence of AKI has been reported to be as low as 0.5% to as high as 23%. AKI was reported to develop at a median of 15 days in one study, and another study reported that most AKI developed within 7 days of admission. The data on acute kidney injury (AKI) in patients with COVID-19 is mostly from patients who are hospitalized, and in some studies limited to critically ill patients in the ICU. In ICU patients the requirement for renal support and mortality is reported to be high, however is a lack of epidemiological studies specifically designed to determine the impact of COVID 19 on kidney outcomes.

The mortality rate of patients with kidney dysfunction varies widely and is inversely related to country income and percentage of gross domestic product spent on total health expenditure. Several initiatives will be very insightful and identified important gaps in knowledge, more effort is required to understand this problem affecting all regions of the globe. In order to eventually implement resources and tools to help prevent, diagnose and treat patients with COVID 19 infection and kidney dysfunction, the investigators need to understand its incidence, risk factors, available resources and barriers to diagnosis and treatment.

This project will collect data on kidney function progression in patients infected with COVID 19 across the world. The study will open to individual physicians across the world who agreed to participate by providing de-identified clinical and lab data of patients with confirmed COVID 19 infection with acute and chronic kidney dysfunction.

Primary Objectives:

1. Establish incidence and outcomes of acute kidney injury (AKI) in different settings worldwide during the COVID 19 pandemic.

Secondary Objectives:

1. Compare risk factors, etiologies, diagnosis, management and outcomes of acute and chronic kidney dysfunction in COVID 19 patients in different countries
2. Determine resources available for recognition, non-dialytic and dialytic management and follow up of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings and countries.
3. Determine long term outcomes, 6 months and 1 year, of patients with acute and chronic kidney dysfunction and COVID 19 infection in different settings.
4. Evaluate barriers preventing access to the standard treatments of acute and chronic kidney dysfunction and COVID 19 infection across different countries.
5. Determine the impact of COVID 19 infection on the progression of acute and chronic kidney disease in patient with native and transplanted kidney.
6. Evaluate the treatment strategies of patient with ESKD on hospitalized patients with COVID 19.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed infection with COVID 19
* Patients with Acute Kidney injury (AKI) or Chronic kidney disease (CKD) or need for dialysis
* Patients receiving Chronic dialysis (hemo or peritoneal dialysis)
* Renal transplant recipients

Exclusion Criteria:

* • Patients \< 18 yrs age

Primary outcomes:
measure: AKI incidence
timeFrame: from hospital admission through hospital discharge upto 24 weeks
measure: Dialysis requirement
timeFrame: through study completion upto 1 year from enrollment
measure: hospital mortality
timeFrame: through study completion within 1 year
Secondary outcomes:
measure: Renal functional recovery
timeFrame: Assessed at at 3, 6 and 12 months from enrollment at hospital admission
measure: Functional status
timeFrame: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission
measure: Resource utilization
timeFrame: Within 1 year of enrollment for primary hospitalization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: New York
country: United States
facility: Jacobi Medical Center
state: New York
city: Cochabamba
country: Bolivia
facility: Hospital Obrero #2
city: Montreal
country: Canada
facility: Hopital Sacre Coeur & Universite de Montreal
state: Quebec
city: Santiago
country: Chile
facility: Universidad de Los Andes
city: Chandigarh
country: India
facility: Postgraduate Institute of Research, Chandigarh
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's & St Thomas's Hospital
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of California, San Diego
name: Ravindra L Mehta
role: PRINCIPAL_INVESTIGATOR
References: