Acute Kidney InjurySPARC-1NCT04466306
Pediatric Acute Kidney Injury in COVID-19
An observational study of Acute Kidney Injury and COVID, run by Children's Healthcare of Atlanta at 47 sites in 7 countries.
Trial summary
This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS… Read more about this study
- Who is it for?
- Ages 7 days to 25 years
- Conditions the study is for
- Acute Kidney Injury, COVID
- How many people
- 400 participants
- Where
- 47 sitesin 7 countries
- Study dates
- 15 Apr 2020to 1 Jul 2021
- How long will I take part?
- 14 Days
- 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 7 days to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients admitted to the pediatric medical, surgical, or cardiac ICU for any condition - with a suspicion for or proven diagnosis of SARS-COV2 (COVID-19).
Who may be able to join
- Patient less than or equal to 25 years of age
- Receiving clinical care in the pediatric intensive care unit (PICU) on a study day in April - June 2020
- Patient considered a "Person Under Investigation" and/or tested positive for SARS-CoV2 (COVID-19)
Who cannot join
- None
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States33 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
John Hopkins Children's Center
Baltimore, Maryland, 21287
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Oishei Children's Hospital of Buffalo
Buffalo, New York, 14203
Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
Levine Children's Hospital
Charlotte, North Carolina, 28203
Comer Children's Hospital - UChicago Medicine
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Duke Children's Hospital and Health Center
Durham, North Carolina, 27705
UF Health Shands Children's Hospital
Gainesville, Florida, 32608
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
Children's Mercy
Kansas City, Kansas, 64108
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Cedars-Sinai Maxine Dunitz Children's Health Center
Los Angeles, California, 90048
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Yale New Haven Children's Hospital
New Haven, Connecticut, 06504
Lucile Packard Children's Hospital Standford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Lifespan Hasbro Children's Hospital
Providence, Rhode Island, 02903
Golisano Children's Hospital - University of Rochester Medicine
Rochester, New York, 14642
Beaumont Children's Hospital
Royal Oak, Michigan, 48073
Rady Children's Hospital San Diego
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital of Washington University
St Louis, Missouri, 63110
Stony Brook Children's Hospital
Stony Brook, New York, 11794
United Kingdom5 sites
Birmingham Children's Hospital NHS
Birmingham, B4 6NH
Alder Hey Children's Hospital NHS
Liverpool
King's College Hospital NHS
London, SE5 9RS
St. George's University Hospital NHS
London, SW17 0QT
Great Ormond Street Hospital NHS
London, WC1N 3JH
Canada3 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2C8
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Israel2 sites
Soroka University Medical Center
Beersheba
Dana-Dwek Children's Hospital
Tel Aviv
Serbia2 sites
Institute for Mother and Child Healthcare
Belgrade
University Children's Hospital
Belgrade
About this study
Official title: SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative
This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.
Read the detailed description
The primary purpose of the data collection will be to provide a descriptive analysis of the burden and characteristics of AKI in children with SARS-CoV2 proven or suspected infection across the world. This is a prospective, point prevalence study. Data collection will occur once a week during the months of April through June 2020.
The protocol for the point prevalence is for each individual participating site to conduct a surveillance study on predetermined dates of their intensive care units (pediatric medical, surgical, cardiac ICUs) for patients by the inclusion and exclusion criteria. The study is strictly observational. Data will only be captured on the predetermined dates listed. The dates have been chosen to reflect the estimated surge and peak of the virus spread in North America, Europe, Africa, Asia, and Australia. The rationale for performing an urgent point prevalence estimation study first, includes the following: a) there is almost no knowledge on AKI rate, severity of AKI or how current pandemic-setting AKI phenotype differs from what we know of AKI in children prior to the pandemic. A rapidly-performed, high feasibility-designed point prevalence estimation study, with minimal data collection will provide rapid, almost instantaneous dissemination of results to the international community. Based on the results of this study, a follow-up study is planned for a full retrospective data collection of all viral positive patients. Understanding the burden of pediatric AKI during this pandemic within the current context of acute health burden in the healthcare settings and enable planning and feasibility evaluation for quality of care measures and potentially for upcoming technology needs and/or sharing of RRT technology with adult care units; b) an urgent point-prevalence estimation study with minimal but key data collection will inform on any changes to design, sample size requirements or data points for the larger granular longitudinal retrospective study.
- Conditions
- Acute Kidney Injury, COVID
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
Measured: 14 days
Secondary outcomes (4)
Survival
Survival to ICU discharge or Day 14
Measured: 14 days
Rate of Extracorporeal Therapy Requirement
The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy
Measured: 14 days
Fluid overload
>20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight
Measured: Day of Enrollment
Rate of nephrotoxic medication exposure
The exposure of enrolled patients to known nephrotoxic medications, including diuretics
Measured: Day of Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Apr 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Children's of Alabama, The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Rajit K Basu, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466306
- Sponsor's protocol ID
- ChildrensHA
- Acronym
- SPARC-1
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative
- ClinicalTrials.gov ID
- NCT04466306
- Acronym / sponsor ID
- SPARC-1 / ChildrensHA
- Conditions
- Acute Kidney Injury, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Children's of Alabama, The Hospital for Sick Children
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 10 Jul 2020 (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.
This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.
Detailed description
The primary purpose of the data collection will be to provide a descriptive analysis of the burden and characteristics of AKI in children with SARS-CoV2 proven or suspected infection across the world. This is a prospective, point prevalence study. Data collection will occur once a week during the months of April through June 2020.
The protocol for the point prevalence is for each individual participating site to conduct a surveillance study on predetermined dates of their intensive care units (pediatric medical, surgical, cardiac ICUs) for patients by the inclusion and exclusion criteria. The study is strictly observational. Data will only be captured on the predetermined dates listed. The dates have been chosen to reflect the estimated surge and peak of the virus spread in North America, Europe, Africa, Asia, and Australia. The rationale for performing an urgent point prevalence estimation study first, includes the following: a) there is almost no knowledge on AKI rate, severity of AKI or how current pandemic-setting AKI phenotype differs from what we know of AKI in children prior to the pandemic. A rapidly-performed, high feasibility-designed point prevalence estimation study, with minimal data collection will provide rapid, almost instantaneous dissemination of results to the international community. Based on the results of this study, a follow-up study is planned for a full retrospective data collection of all viral positive patients. Understanding the burden of pediatric AKI during this pandemic within the current context of acute health burden in the healthcare settings and enable planning and feasibility evaluation for quality of care measures and potentially for upcoming technology needs and/or sharing of RRT technology with adult care units; b) an urgent point-prevalence estimation study with minimal but key data collection will inform on any changes to design, sample size requirements or data points for the larger granular longitudinal retrospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 7 days to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to the pediatric medical, surgical, or cardiac ICU for any condition - with a suspicion for or proven diagnosis of SARS-COV2 (COVID-19).
Key inclusion criteria (3 listed)
- Patient less than or equal to 25 years of age
- Receiving clinical care in the pediatric intensive care unit (PICU) on a study day in April - June 2020
- Patient considered a "Person Under Investigation" and/or tested positive for SARS-CoV2 (COVID-19)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Kidney Injury (AKI)
Time frame: 14 days
Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
4 secondary outcomes
Survival
Time frame: 14 days
Rate of Extracorporeal Therapy Requirement
Time frame: 14 days
Fluid overload
Time frame: Day of Enrollment
Rate of nephrotoxic medication exposure
Time frame: Day of Enrollment
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 3 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Rajit K Basu, MD principal investigator
Children's Healthcare of Atlanta
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and COVID, run by Children's Healthcare of Atlanta at 47 sites in 7 countries.
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 3 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, United Kingdom, Canada, Israel, Serbia and 2 more countries. 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?
Acute Kidney Injury (AKI) (time frame: 14 days). 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 3 Dec 2021.