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Sponsor: University of Washington
Conditions: Acute Kidney Failure, Acute Kidney Insufficiency, Acute Renal Failure, Acute Renal Injury, Acute Renal Insufficiency
Countries: United States
Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to leverage effectively as a group to better understand kidney disease. This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Patients 18 years of age or older admitted to participating hospitals with a positive COVID-19 test result or Persons Under Investigation with suspected COVID-19 infection AND with AKI or at high risk of AKI in the setting of COVID-19 infection, as defined by any ONE of the following: * pre-existing chronic kidney disease as defined by eGFR less than 60 ml/min/1.73 m2 * history of diabetes mellitus established by at least one of the following criteria: * Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year * Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year * Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents) * International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes * requiring use of vasopressors * requiring use of mechanical ventilation AKI is defined by temporal changes in serum creatinine meeting KDIGO Stage 1 criteria or greater (0.3 rise in serum creatinine over baseline value). If a baseline serum creatinine is not available, the patient can be enrolled with an estimated Baseline serum creatinine (see KPMP COVID-19 Manual of Procedures table 1) Exclusion Criteria: Any potential participant meeting any one of the general or safety exclusion criteria will not be eligible for enrollment in the KPMP COVID-19 Substudy. Exclusion criteria include non-transient conditions that would not allow for enrollment in the main KPMP study. Determined at time of Eligibility Assessment prior to consent: * Non-English or Spanish language * Less than 18 years of age * Severe allergy to iodinated contrast * Transplant recipient (kidney or non-kidney, including solid organ and bone marrow transplantation) * Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study) * Inability to provide informed consent or obtain surrogate consent from a legally authorized representative (LAR) * Unwilling to receive blood transfusion (if needed) * Baseline eGFR less than 15 ml/min/m2 If known at the time of enrollment, or determined by kidney ultrasound before the biopsy procedure (may be the same day as the biopsy procedure) * Kidney size less than 8 cm (percutaneous biopsies only) * Solitary or single functioning kidney * Evidence of urinary tract obstruction or hydronephrosis * Multiple bilateral kidney cysts
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Dallas, Texas, United States