Severe Sepsis in Children - IMPRESS-C

Last updated: December 7, 2020
Sponsor: University of Florida
Overall Status: Trial Not Available

Phase

N/A

Condition

Renal Failure

Kidney Disease

Nephropathy

Treatment

N/A

Clinical Study ID

NCT02598674
IRB201500264
  • Ages 7-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.

Eligibility Criteria

Inclusion

Inclusion Criteria: For all patients:

  • Ability to assent (age 7-17 at time of participation in the study)
  • If taking antihypertensive medication, prescribing practitioner's written approval toparticipate For sAKI patients:
  • Hospitalization with a diagnosis of sepsis from 1998-2014
  • Severe AKI as defined by the pEDRIFLE criteria during incident sepsis admission
  • Participation in cognitive survey study with completion of the PedsQL survey For healthy control patients:

• Patients from the neurology service undergoing MRI with gadolinium as a part of theirclinical care

Exclusion

Exclusion Criteria: For all patients:

  • Known pre-existing CKD as defined by history of kidney transplant or long-termdialysis
  • Age greater than 17 years at the time of incident sepsis admission
  • AKI from primary kidney disease including acute glomerulonephritis and obstructiveuropathy
  • Pregnancy at the time of enrollment
  • Known or suspected allergy to gadolinium based contrast
  • Known or suspected allergy to iodohippurate will be excluded from RPF measurement withiodohippurate
  • Heart failure or condition whereby the administration of 0.9% normal saline would becontraindicated
  • If taking antihypertensive medication, lack of prescribing practitioner's writtenapproval to participate For healthy control patients:
  • Chronic kidney disease
  • History of acute kidney injury or GFR <100 History of chronic illnesses deemed topredispose to renal or cardiovascular dysfunction or abnormalities Suspicion ofinfection
  • Neuro-vascular history such as encephalitis, meningitis, vascular anomalies of thebrain or spinal cord or cerebrovascular infarct or ischemia will be excluded .
  • No indication for gadolinium administration for MRI

Study Design

Study Start date:
October 01, 2019
Estimated Completion Date:
September 30, 2021

Study Description

This will be a two-arm cross-sectional control-cohort outpatient evaluation. Subjects with sAKI and control subjects (age and gender matched) will be recruited from neurology service. Subjects will be asked to come in to the Clinical Research Center for 24-hour monitoring and participate in the outpatient study where urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by blood pressure monitoring, peripheral arterial and applanation tonometry.

Connect with a study center

  • UF Health

    Gainesville, Florida 32608
    United States

    Site Not Available

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