Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults (IMPRESS-YA)

University of Florida

Status: Withdrawn

Conditions: Chronic Kidney Disease; Hypertension; Acute Kidney Injury

Treatments: Procedure: Pulse Wave Velocity; Drug: Gadolinium; Procedure: Peripheral Arterial Tonometry; Procedure: 24 hour ambulatory Blood Pressure; Drug: Iodohippurate

Study type: Observational

Funder types: Other

Identifiers

NCT02599844

IRB201500238

Details and patient eligibility

About

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.

Full description

This will be a two-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.

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For all patients:

• Age 18-24 at time of participation in the study

For non-AKI sepsis patients:

• Hospitalization with a diagnosis of sepsis from 1998-2014
• Failure to meet pEDRIFLE criteria for AKI during incident sepsis admission
• Participation in cognitive survey study with completion of the PedsQL survey

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

Exclusion criteria

For all patients:

• Known pre-existing CKD as defined by history of kidney transplant or long-term dialysis
• Age greater than 18 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 iodine or shellfish will be excluded from RPF measurement with iodohippurate
• Heart failure or condition whereby the administration of 0.9% normal saline would be contraindicated

Trial design

0 participants in 2 patient groups

Sepsis with Severe AKI

Description:

This group will have a history of pediatric admission with sepsis-related Acute Kidney Injury (sAKI) which lead to classification of "injury" or "failure". The following test will be performed: urinary and serum studies to measure glomerular filtration rate by using gadolinium, renal plasma flow by using an injection of non-radioactive iodohippurate, followed by cardiovascular assessments using 24 hour ambulatory blood pressure monitoring, peripheral arterial tonometry and pulse wave velocities (PWV).

Treatment:

Procedure: Pulse Wave Velocity

Drug: Iodohippurate

Procedure: Peripheral Arterial Tonometry

Drug: Gadolinium

Procedure: 24 hour ambulatory Blood Pressure

Sepsis without AKI

Description:

This group will have a history of a pediatric admission with sepsis which lead to no classification of sepsis-related Acute Kidney Injury (sAKI). The following test will be performed: urinary and serum studies to measure glomerular filtration rate by using gadolinium, renal plasma flow by using an injection of non-radioactive iodohippurate, followed by cardiovascular assessments using 24 hour ambulatory blood pressure monitoring, peripheral arterial tonometry and pulse wave velocities (PWV).

Treatment:

Procedure: Pulse Wave Velocity

Drug: Iodohippurate

Procedure: Peripheral Arterial Tonometry

Drug: Gadolinium

Procedure: 24 hour ambulatory Blood Pressure