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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Qatar1 site
  • Hamad General corporation

    Doha, 3050

Other trials in Qatar

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.

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.

  1. 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.

  1. First posted9 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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)
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

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.

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