Severe Sepsis in Children - IMPRESS-C

Withdrawn before enrolling

Conditions studied: Acute Kidney Injury, Chronic Kidney Disease, Hypertension

In brief

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.

Key facts

Study ID: NCT02598674
Run by: University of Florida
People needed: 0
Starts: 2019-10-01
Expected to finish: 2021-09-01
Last updated by the study team: 2020-12-09

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 to participate
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 their clinical care

You may not qualify if…

For all patients:
Known pre-existing CKD as defined by history of kidney transplant or long-term dialysis
Age greater than 17 years at the time of incident sepsis admission
AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
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 with iodohippurate
Heart failure or condition whereby the administration of 0.9% normal saline would be contraindicated
If taking antihypertensive medication, lack of prescribing practitioner's written approval to participate
For healthy control patients:
Chronic kidney disease
History of acute kidney injury or GFR <100 History of chronic illnesses deemed to predispose to renal or cardiovascular dysfunction or abnormalities Suspicion of infection
Neuro-vascular history such as encephalitis, meningitis, vascular anomalies of the brain or spinal cord or cerebrovascular infarct or ischemia will be excluded .
No indication for gadolinium administration for MRI

Where it is running

UF Health — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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