Acute Kidney InjuryRIHCCNCT04788394
Renal Involvement in Hospitalized Children With COVID-19
An observational study of Acute Kidney Injury and Covid19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Acute Kidney Injury, Covid19, Renal Dysfunction
- What is being tested?
- data review and data comparing
- How many people
- 400 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 years
- All sexes
- Child
Study population: This retrospective review of electronic medical records from the pediatric division, Hamad General hospital in Doha, Qatar, will include all hospitalized children (0-14 years) who were diagnosed with COVID-19 between March 1, 2020, to January 1, 2021. Data collection will be done by co-investigators for all patients.
Who may be able to join
- All pediatric patients with COVID-19 were admitted to Hamad Hospital from (0 to 14) years, using the electronic medical records (Cerner), over that time period (from March 1, to January 1, 2021), with one of the following:
- Proteinuria: (≥1+) on dipstick analysis.
- Hematuria: ≥ 5 RBC/HPF.
- Sterile Pyuria: ≥ 5 WBC/HPF or ≥10 WBC/mm3 with negative urine culture (44).
- Hypernatremia :> 145meq/l.
- Hyponatremia: < 135 meq/l.
Show all 11Show fewer
- Hypokalemia :< 3.5meq/l.
- Metabolic acidosis (ph <7.35).
- Elevated serum creatinine :> upper limit of reference interval (ULRI) values.
- Elevated serum urea: > 7 mmol/l.
- Urine specific gravity (SG) <1.003.
Who cannot join
- Patient with previous chronic kidney diseases.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 0.5% 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 5,500 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 μmol/L or serum urea greater than 7 mmol/L.
This retrospective, exploratory, descriptive study aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 in Qatar.
- Conditions
- Acute Kidney Injury, Covid19, Renal Dysfunction, Coronavirus Infection, AKI, Pediatric Kidney Disease
- Being tested
- data review, data comparing
- Medical subject headings
- Acute Kidney Injury, COVID-19, Renal Insufficiency, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data reviewOther
In this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records since 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included:
- Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia).
- Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection [40].
- Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine:
data comparingOther
In this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory-confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records since 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included:
- Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia).
- Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection [40].
- Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine:
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the prevalence of renal dysfunction in hospitalized children with COVID19 in Qatar.
explore and describe the rate of renal symptoms and signs, and severity in pediatric patients admitted to the hospital with COVID 19 in Qatar . The relation between severity of disease and age , weight , gender ,and nationality of participants .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alhandi Omar Helal, Principal investigator, Hamad Medical CorporationMahmoud Helal, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788394
- Sponsor's protocol ID
- MRC01-21-089
- Acronym
- RIHCC
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Involvement in Hospitalized Children With COVID-19
- ClinicalTrials.gov ID
- NCT04788394
- Acronym / sponsor ID
- RIHCC / MRC01-21-089
- Conditions
- Acute Kidney Injury, Covid19, Renal Dysfunction, Coronavirus Infection, AKI, Pediatric Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 0.5% 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 5,500 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 μmol/L or serum urea greater than 7 mmol/L.
This retrospective, exploratory, descriptive study aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 in Qatar.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- This retrospective review of electronic medical records from the pediatric division, Hamad General hospital in Doha, Qatar, will include all hospitalized children (0-14 years) who were diagnosed with COVID-19 between March 1, 2020, to January 1, 2021. Data collection will be done by co-investigators for all patients.
Key inclusion criteria (11 listed)
- All pediatric patients with COVID-19 were admitted to Hamad Hospital from (0 to 14) years, using the electronic medical records (Cerner), over that time period (from March 1, to January 1, 2021), with one of the following:
- Proteinuria: (≥1+) on dipstick analysis.
- Hematuria: ≥ 5 RBC/HPF.
- Sterile Pyuria: ≥ 5 WBC/HPF or ≥10 WBC/mm3 with negative urine culture (44).
- Hypernatremia :> 145meq/l.
Key exclusion criteria (1 listed)
- Patient with previous chronic kidney diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data reviewIn this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records since 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included: * Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia). * Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection [40]. * Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine: | Other | – |
| data comparingIn this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory-confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records since 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included: * Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia). * Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection [40]. * Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine: | Other | – |
Primary outcome
determine the prevalence of renal dysfunction in hospitalized children with COVID19 in Qatar.
Time frame: 1 year
explore and describe the rate of renal symptoms and signs, and severity in pediatric patients admitted to the hospital with COVID 19 in Qatar . The relation between severity of disease and age , weight , gender ,and nationality of participants .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alhandi Omar Helal principal investigator
Hamad Medical Corporation
Mahmoud Helal principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Covid19, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the prevalence of renal dysfunction in hospitalized children with COVID19 in Qatar. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.