Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788394
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2021-03-07
Brief Title:
Renal Involvement in Hospitalized Children With COVID-19
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Renal Involvement in Hospitalized Children With COVID-19
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIHCC
Brief Summary:
Covid-19 is an important human and animal pathogen it mostly causes respiratory and gastrointestinal symptoms Clinical features range from a common cold to severe diseases such as severe acute respiratory distress syndrome bronchitis pneumonia multi-organ failure and even death It seems to be less commonly affecting children and to cause fewer symptoms and less severe disease in this age group compared with adults Clinicians have observed many extrapulmonary manifestations of COVID-19 as hematologic cardiovascular renal gastrointestinal and hepatobiliary endocrinologic neurologic ophthalmologic and dermatologic systems can all be affected This retrospective study that will be conducted at Hamad General Hospital in Qatar aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 from March 1 2020 to January 1 2021
Detailed Description:
COVID-19 usually causes respiratory and gastrointestinal symptoms Clinical features range from a common cold to severe diseases such as bronchitis pneumonia severe acute respiratory distress syndrome multi-organ failure and even death SARS-CoV MERS-CoV and SARS-CoV-2 seem to less commonly affect children and to cause fewer symptoms and less severe disease in this age group compared with adults and are associated with much lower case-fatality rates Coronaviruses are a large family of enveloped single-stranded zoonotic RNA viruses Clinicians have observed many extrapulmonary manifestations of COVID-19 as hematologic cardiovascular renal and gastrointestinal and hepatobiliary endocrinologic neurologic ophthalmologic and dermatologic systems can all be affected
Acute kidney injury AKI is a frequent complication of COVID-19 and is associated with mortality In adults the incidence of AKI in hospitalized patients with COVID-19 ranged from 05 to 29 and occurred within a median of 7-14 days after admission Studies from the USA have reported much higher rates of AKI In a study of nearly 5500 patients admitted with COVID-19 in a New York City hospital system AKI occurred in 37 with 14 of the patients requiring dialysis AKI occurred at much higher rates in critically ill patients admitted to New York City hospitals ranging from 78 to 90 Of 257 adult patients admitted to ICUs in a study from New York City 31 received renal replacement therapy RRT Furthermore hematuria has been reported in nearly half of patients with COVID-19 and proteinuria has been reported in up to 87 of critically ill patients with COVID-19 11 Hyperkalemia and acidosis are common electrolyte abnormalities seen in patients with COVID-19 even among patients without AKI COVID-19 is also increasingly reported among patients with end-stage renal disease and kidney transplant recipients with higher mortality rates than those seen in the general population
Children and adolescents with COVID-19 fare considerably better than adults with mortality rates in pediatric patients age 18 years of less than 1 reported in early studies The most common clinical features in children described in the literature are fever dry cough and pneumonia However multisystem involvement is increasingly being recognized including the development of hyperinflammatory shock
In other studies acute kidney injury has been reported in adult patients with COVID-19 with a high prevalence across inpatient admissions 7 and admissions to adult intensive care units ICUs 23 as first reported in Wuhan China In adult patients with COVID-19 acute kidney injury is related to increased mortality risk even after adjustment for age sex and comorbidities In addition a large proportion of adults have proteinuria 44 and hematuria 27 at presentation despite an elevated serum creatinine prevalence of only 16
In children there is scanty data compared to adults Douglas et al studied 52 pediatric patients ages 0-16 years admitted to Great Ormond Street Hospital for Children NHS Foundation Trust London UK since March 25 2020 with confirmed severe acute respiratory syndrome coronavirus infection and diagnosed by either a positive PCR result or seropositivity Of the 52 inpatients 24 46 had a serum creatinine greater than the upper limit of reference interval ULRI 22 42 had proteinuria and hematuria was found in 40 77 patients Qui and colleagues 18 did not find any renal dysfunction in 36 hospitalized pediatric patients ages 0-16 years with COVID-19 in China Renal dysfunction defined by a serum creatinine greater than 110 μmolL or serum urea greater than 7 mmolL
This retrospective exploratory descriptive study aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 in Qatar
Acute kidney injury AKI is a frequent complication of COVID-19 and is associated with mortality In adults the incidence of AKI in hospitalized patients with COVID-19 ranged from 05 to 29 and occurred within a median of 7-14 days after admission Studies from the USA have reported much higher rates of AKI In a study of nearly 5500 patients admitted with COVID-19 in a New York City hospital system AKI occurred in 37 with 14 of the patients requiring dialysis AKI occurred at much higher rates in critically ill patients admitted to New York City hospitals ranging from 78 to 90 Of 257 adult patients admitted to ICUs in a study from New York City 31 received renal replacement therapy RRT Furthermore hematuria has been reported in nearly half of patients with COVID-19 and proteinuria has been reported in up to 87 of critically ill patients with COVID-19 11 Hyperkalemia and acidosis are common electrolyte abnormalities seen in patients with COVID-19 even among patients without AKI COVID-19 is also increasingly reported among patients with end-stage renal disease and kidney transplant recipients with higher mortality rates than those seen in the general population
Children and adolescents with COVID-19 fare considerably better than adults with mortality rates in pediatric patients age 18 years of less than 1 reported in early studies The most common clinical features in children described in the literature are fever dry cough and pneumonia However multisystem involvement is increasingly being recognized including the development of hyperinflammatory shock
In other studies acute kidney injury has been reported in adult patients with COVID-19 with a high prevalence across inpatient admissions 7 and admissions to adult intensive care units ICUs 23 as first reported in Wuhan China In adult patients with COVID-19 acute kidney injury is related to increased mortality risk even after adjustment for age sex and comorbidities In addition a large proportion of adults have proteinuria 44 and hematuria 27 at presentation despite an elevated serum creatinine prevalence of only 16
In children there is scanty data compared to adults Douglas et al studied 52 pediatric patients ages 0-16 years admitted to Great Ormond Street Hospital for Children NHS Foundation Trust London UK since March 25 2020 with confirmed severe acute respiratory syndrome coronavirus infection and diagnosed by either a positive PCR result or seropositivity Of the 52 inpatients 24 46 had a serum creatinine greater than the upper limit of reference interval ULRI 22 42 had proteinuria and hematuria was found in 40 77 patients Qui and colleagues 18 did not find any renal dysfunction in 36 hospitalized pediatric patients ages 0-16 years with COVID-19 in China Renal dysfunction defined by a serum creatinine greater than 110 μmolL or serum urea greater than 7 mmolL
This retrospective exploratory descriptive study aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 in Qatar
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None