Severe Sepsis in Children - IMPRESS-C
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Hospital, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 2/8/2019 |
| Start Date: | April 2019 |
| End Date: | July 2019 |
| Contact: | Marie-Carmelle Elie, MD |
| Email: | elie@ufl.edu |
| Phone: | 352-265-5911 |
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
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.
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.
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.
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.
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 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
Exclusion Criteria:
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
We found this trial at
1
site
Gainesville, Florida 32608
Principal Investigator: Marie-Carmelle Elie, MD
Phone: 352-265-5911
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