IMPRESS: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

Sponsor

University of Florida (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02372721

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Chronic Kidney Disease Hypertension

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Sepsis with Severe AKI History of a pediatric admission with sepsis related AKI which lead to classification of "injury" or "failure". This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry.
Sepsis without AKI History of a pediatric admission with sepsis which lead to no classification of AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry.
Control No history of an admission for AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry.

Outcome Measures

Primary Outcome Measures

Chronic Kidney Disease [Day 2]
Obtaining preliminary estimates of glomerular function, renal plasma flow, proteinuria, cystatin C and microalbuminuria in children with and without a history of acute kidney injury in order to assess the presence of chronic kidney disease.

Secondary Outcome Measures

Hypertension [24 hours]
Ambulatory blood pressure (BP) monitoring, peripheral arterial and applanation tonometry will be performed. A subject will be considered hypertensive if systolic and/or diastolic blood pressure is >95th percentile for sex, age, and height.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Hospitalization with a diagnosis of sepsis from 1998-2014
Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for AKI during incident admission.
Participation in cognitive survey study with completion of survey

For sepsis related AKI patients:

Hospitalization with a diagnosis of sepsis from 1998-2014
Need for renal replacement therapy (RRT)
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
Participation in cognitive survey study with completion of survey

For healthy control patients:

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

Exclusion Criteria:

For all patients:

Known pre-existing chronic kidney disease (CKD) as defined by history of kidney transplant or long-term dialysis
Age greater than 18 years at the time of sepsis admission
AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
Pregnancy at the time of enrollment
Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment.