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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Covid19; AKI; ESRD; CKD; Transplant;Failure,Kidney

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Bolivia
  • Cochabamba, Bolivia
    • Hospital Obrero #2
• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Hopital Sacre Coeur & Universite de Montreal
• Chile
  • Santiago, Chile
    • Universidad de Los Andes
• India
  • Chandigarh, India
    • Postgraduate Institute of Research, Chandigarh
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's & St Thomas's Hospital
  • Nottingham, United Kingdom, NG7 2RD
    • University of Nottingham
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama, Birmingham
  • California
    • San Diego, California, United States, 92103
      • University of California, San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • New York
    • Albany, New York, United States, 12208
      • St. Peter's Hospital
    • New York, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Kidney disease in COVID-19; Chronic Kidney Disease (CKD): Known diagnosis of chronic kidney disease; prior evidence of markers of kidney damage for 3 months (microalbuminuria, proteinuria >300mg/24 hrs or abnormalities in imaging tests) or the presence of glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months calculated with CKD-EPI equation, with or without other signs of kidney damage as described above. ESKD: Patients that are dialysis dependent. Suspected AKI: Oliguria (<200 mL/6 hours) and any AKI-related clinical signs or symptoms (see table 1) or urinalysis/dipstick abnormality. All suspected AKI cases must be confirmed prior to enrollment. Confirmed AKI: 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 Functioning Kidney transplant:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dialysis requirement	initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay	through study completion upto 1 year from enrollment
hospital mortality	Deaths during primary hospitalization	through study completion within 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Ravindra L Mehta, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: dialysis; CKD; COVID19; mortality; renal transplant; AKI; renal recovery; resource utilization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Urologic Diseases; COVID-19; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 000295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participating sites will have acess to their own data and aggregate data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No