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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04491227
• Other study ID #: 000295
• Status: Enrolling by invitation
• Start date: May 5, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: March 31, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AKI
• CKD
• Covid19
• ESRD
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Transplant;Failure,Kidney

Locations

Country	Name	City	State
Bolivia	Hospital Obrero #2	Cochabamba
Canada	Hopital Sacre Coeur & Universite de Montreal	Montreal	Quebec
Chile	Universidad de Los Andes	Santiago
India	Postgraduate Institute of Research, Chandigarh	Chandigarh
United Kingdom	Guy's & St Thomas's Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	University of Nottingham	Nottingham
United States	St. Peter's Hospital	Albany	New York
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Jacobi Medical Center	New York	New York
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Countries where clinical trial is conducted

United States,  Bolivia,  Canada,  Chile,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI incidence	Meeting of at least one of the modified KDIGO Criteria; Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours; Increase or decrease in serum creatinine > 50% from reference in 7 days; Urine output < 400 ml/day	from hospital admission through hospital discharge upto 24 weeks
Primary	Dialysis requirement	initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay	through study completion upto 1 year from enrollment
Primary	hospital mortality	Deaths during primary hospitalization	through study completion within 1 year
Secondary	Renal functional recovery	C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent	Assessed at at 3, 6 and 12 months from enrollment at hospital admission
Secondary	Functional status	EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment	questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission
Secondary	Resource utilization	Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay	Within 1 year of enrollment for primary hospitalization