Clinical trial NCT02372721: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
Official title: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Kidney Injury
Chronic Kidney Disease
Hypertension
Keywords: acute kidney injury
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We intend to contact and enroll patients with severe sepsis related AKI patients without sepsis related AKI and a sample of age and sex-matched healthy controls

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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)

Primary outcomes:
measure: Chronic Kidney Disease
timeFrame: Day 2
Secondary outcomes:
measure: Hypertension
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Marie-Carmelle Elie, MD
role: PRINCIPAL_INVESTIGATOR
References: