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

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ClinicalTrials.gov Identifier: NCT04491227
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Ravindra Mehta, University of California, San Diego

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.


Condition or disease
Covid19 AKI CKD ESRD 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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:




Primary Outcome Measures :
  1. AKI incidence [ Time Frame: from hospital admission through hospital discharge upto 24 weeks ]

    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

  2. Dialysis requirement [ Time Frame: through study completion upto 1 year from enrollment ]
    initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay

  3. hospital mortality [ Time Frame: through study completion within 1 year ]
    Deaths during primary hospitalization


Secondary Outcome Measures :
  1. Renal functional recovery [ Time Frame: Assessed at at 3, 6 and 12 months from enrollment at hospital admission ]
    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

  2. Functional status [ Time Frame: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission ]
    EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment

  3. Resource utilization [ Time Frame: Within 1 year of enrollment for primary hospitalization ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491227


Locations
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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, New York
St. Peter's Hospital
Albany, New York, United States, 12208
Jacobi Medical Center
New York, New York, United States, 10461
Bolivia
Hospital Obrero #2
Cochabamba, Bolivia
Canada, Quebec
Hopital Sacre Coeur & Universite de Montreal
Montreal, Quebec, Canada
Chile
Universidad de Los Andes
Santiago, Chile
India
Postgraduate Institute of Research, Chandigarh
Chandigarh, India
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Guy's & St Thomas's Hospital
London, United Kingdom, SE1 7EH
University of Nottingham
Nottingham, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Ravindra L Mehta University of California, San Diego
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Responsible Party: Ravindra Mehta, Recall Faculty, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04491227    
Other Study ID Numbers: 000295
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participating sites will have acess to their own data and aggregate data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ravindra Mehta, University of California, San Diego:
AKI
dialysis
CKD
COVID19
renal transplant
mortality
renal recovery
resource utilization
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases