Severe Sepsis in Children - IMPRESS-C

University of Florida

Status: Withdrawn

Conditions: Chronic Kidney Disease; Hypertension; Acute Kidney Injury

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

Study type: Observational

Funder types: Other

Identifiers

NCT02598674

IRB201500264

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 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.

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

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: Peripheral Arterial Tonometry

Drug: Gadolinium

Drug: Iodohippurate

Procedure: Pulse Wave Velocity

Procedure: 24 hour ambulatory Blood Pressure

Control

Description:

This group will not have a history of pediatric admission with sepsis-related Acute Kidney Injury (sAKI). The following test will be performed: urinary and serum studies to measure glomerular filtration rate by using gadolinium, followed by cardiovascular assessments using 24 hour ambulatory blood pressure monitoring, peripheral arterial tonometry and pulse wave velocities (PWV).

Treatment:

Procedure: Peripheral Arterial Tonometry

Drug: Gadolinium

Procedure: Pulse Wave Velocity

Procedure: 24 hour ambulatory Blood Pressure