Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
Overview
- Phase
- Not Applicable
- Intervention
- Iodohippurate
- Conditions
- Acute Kidney Injury
- Sponsor
- University of Florida
- Locations
- 1
- Primary Endpoint
- Renal plasma flow (RPF) filtration
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
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:
Arms & Interventions
Sepsis with Severe AKI
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).
Intervention: Iodohippurate
Sepsis with Severe AKI
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).
Intervention: 24 hour ambulatory Blood Pressure
Sepsis with Severe AKI
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).
Intervention: Peripheral Arterial Tonometry
Sepsis with Severe AKI
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).
Intervention: Pulse Wave Velocity
Sepsis with Severe AKI
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).
Intervention: Gadolinium
Control
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).
Intervention: 24 hour ambulatory Blood Pressure
Control
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).
Intervention: Peripheral Arterial Tonometry
Control
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).
Intervention: Pulse Wave Velocity
Control
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).
Intervention: Gadolinium
Outcomes
Primary Outcomes
Renal plasma flow (RPF) filtration
Time Frame: Day 2
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF) filtration.
Proteinuria will be measured in the urine
Time Frame: Day 2
Proteinuria may be a sign of renal (kidney) damage. Since serum proteins are readily reabsorbed from urine, the presence of excess protein indicates either an insufficiency of absorption or impaired filtration. People with diabetes may have damaged nephrons and develop proteinuria.
Glomerular Function Rate (GFR) filtration
Time Frame: Day 2
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
Cystatin C will be measured in the blood
Time Frame: Day 2
Cystatin C can be measured in a random sample of serum (the fluid in blood from which the red blood cells and clotting factors have been removed) using immunoassays such as nephelometry or particle-enhanced turbidimetry.
Secondary Outcomes
- Peripheral Arterial Tonometry(24 hours)
- Pulse wave velocity(24 hours)
- 24 hour ambulatory Blood Pressure(24 hours)