We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Pediatric Acute Kidney Injury in COVID-19 (SPARC-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04466306
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : December 3, 2021
Children's Hospital Medical Center, Cincinnati
Children's of Alabama
The Hospital for Sick Children
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

Brief 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 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.

Condition or disease
Acute Kidney Injury COVID

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative
Actual Study Start Date : April 15, 2020
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Acute Kidney Injury (AKI) [ Time Frame: 14 days ]
    Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output

Secondary Outcome Measures :
  1. Survival [ Time Frame: 14 days ]
    Survival to ICU discharge or Day 14

  2. Rate of Extracorporeal Therapy Requirement [ Time Frame: 14 days ]
    The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy

  3. Fluid overload [ Time Frame: Day of Enrollment ]
    >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight

  4. Rate of nephrotoxic medication exposure [ Time Frame: Day of Enrollment ]
    The exposure of enrolled patients to known nephrotoxic medications, including diuretics

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   7 Days to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).

Inclusion Criteria:

  • 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)

Exclusion Criteria:

• None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466306

Show Show 47 study locations
Sponsors and Collaborators
Children's Healthcare of Atlanta
Children's Hospital Medical Center, Cincinnati
Children's of Alabama
The Hospital for Sick Children
Layout table for investigator information
Principal Investigator: Rajit K Basu, MD Children's Healthcare of Atlanta
Layout table for additonal information
Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT04466306    
Other Study ID Numbers: ChildrensHA
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases