Clinical trial NCT02598674: Severe Sepsis in Children - IMPRESS-C
Official title: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
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Overall status: WITHDRAWN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
Collaborators: name: American Society of Nephrology
First posted: 2015-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contact and enroll subjects with severe sepsis related AKI subjects 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glomerular Function Rate (GFR) filtration
timeFrame: Day 2
measure: Renal plasma flow (RPF) filtration
timeFrame: Day 2
measure: Proteinuria will be measured in the urine
timeFrame: Day 2
measure: Cystatin C will be measured in the blood
timeFrame: Day 2
Secondary outcomes:
measure: 24 hour ambulatory Blood Pressure
timeFrame: 24 hours
measure: Peripheral Arterial Tonometry
timeFrame: 24 hours
measure: Pulse wave velocity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Marie-Carmelle Elie, MD
role: PRINCIPAL_INVESTIGATOR
References: