Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis



Status:Not yet recruiting
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:5 - 24
Updated:10/31/2015
Start Date:May 2015
End Date:May 2018
Contact:Marie-Carmelle Elie, MD
Phone:352-265-5911

Use our guide to learn which trials are right for you!

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.

This will be a three-arm cross-sectional control-cohort outpatient evaluation. Subjects with
sAKI and a random selection of non-sAKI subjects who agree to participate in another study
of quality of life survey will be asked to participate in the outpatient study. 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.

For non-acute kidney injury (AKI) sepsis patients:

1. Hospitalization with a diagnosis of sepsis from 1998-2014

2. Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for
AKI during incident admission.

3. Participation in cognitive survey study with completion of survey

For sepsis related AKI patients:

1. Hospitalization with a diagnosis of sepsis from 1998-2014

2. Need for renal replacement therapy (RRT)

3. Severe AKI as defined by the pRIFLE criteria (estimated CrCl (eCrCl) decrease by 50%,
eCrCl <60 ml/min/1.73 m2, or a urine output <0.5 ml/kg/h for 24 h or anuric for 12 h)
during the sepsis admission

4. Participation in cognitive survey study with completion of survey

For healthy control patients:

1. Identified from the neurology service who are scheduled for MRI with gadolinium as part
of their clinical care

Exclusion Criteria:

For all patients:

1. Known pre-existing chronic kidney disease (CKD) as defined by history of kidney
transplant or long-term dialysis

2. Age greater than 18 years at the time of sepsis admission

3. AKI from primary kidney disease including acute glomerulonephritis and obstructive
uropathy

4. Pregnancy at the time of enrollment

5. Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time
of enrollment.

For healthy control patients:

1. Chronic kidney injury (CKD)

2. History of acute kidney injury

3. History of any chronic illnesses (e.g. cancer)
We found this trial at
1
site
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials