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Severe Sepsis in Children - IMPRESS-C (IMPRESS-C)

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ClinicalTrials.gov Identifier: NCT02598674
Recruitment Status : Withdrawn (Expired IRB)
First Posted : November 6, 2015
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
American Society of Nephrology
Information provided by (Responsible Party):
University of Florida

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
Acute Kidney Injury Chronic Kidney Disease Hypertension Drug: Iodohippurate Procedure: 24 hour ambulatory Blood Pressure Procedure: Peripheral Arterial Tonometry Procedure: Pulse Wave Velocity Drug: Gadolinium

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.

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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 in in Children - IMPRESS-C
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
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).
Drug: Iodohippurate
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
Other Name: RPF filtration

Procedure: 24 hour ambulatory Blood Pressure
Ambulatory blood pressure (BP) monitoring will be performed using a commercially available device (TIBA Ambulo 2400) for 24 hours with measurements every 30 minutes while awake and every hour during sleep.

Procedure: Peripheral Arterial Tonometry
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.

Procedure: Pulse Wave Velocity
Carotid-femoral and carotid-radial pulse wave velocities (PWV), validated markers of individual cardiovascular risk, will be determined by applanation tonometry using SphygmoCorVx technology (AtCor Medical). PWV is an index of the overall stiffness of a vascular segment between measurement sites 59. Thus, while carotid-femoral PWV is an index of the overall stiffness of proximal (central) arteries, the overall stiffness of peripheral arteries contributes relatively more to carotid-radial PWV.

Drug: Gadolinium
Dotarem Gadolinium (GD)- Gadoterate Meglumine (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
  • Dotarem Gadolinium (GD)
  • Glomerular Function Rate (GFR) filtration

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).
Procedure: 24 hour ambulatory Blood Pressure
Ambulatory blood pressure (BP) monitoring will be performed using a commercially available device (TIBA Ambulo 2400) for 24 hours with measurements every 30 minutes while awake and every hour during sleep.

Procedure: Peripheral Arterial Tonometry
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.

Procedure: Pulse Wave Velocity
Carotid-femoral and carotid-radial pulse wave velocities (PWV), validated markers of individual cardiovascular risk, will be determined by applanation tonometry using SphygmoCorVx technology (AtCor Medical). PWV is an index of the overall stiffness of a vascular segment between measurement sites 59. Thus, while carotid-femoral PWV is an index of the overall stiffness of proximal (central) arteries, the overall stiffness of peripheral arteries contributes relatively more to carotid-radial PWV.

Drug: Gadolinium
Dotarem Gadolinium (GD)- Gadoterate Meglumine (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
  • Dotarem Gadolinium (GD)
  • Glomerular Function Rate (GFR) filtration




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 24 hour ambulatory Blood Pressure [ Time Frame: 24 hours ]
    Ambulatory blood pressure (BP) monitoring will be performed using a commercially available device (TIBA Ambulo 2400) for 24 hours with measurements every 30 minutes while awake and every hour during sleep.

  2. Peripheral Arterial Tonometry [ Time Frame: 24 hours ]
    The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.

  3. Pulse wave velocity [ Time Frame: 24 hours ]
    Carotid-femoral and carotid-radial pulse wave velocities (PWV), validated markers of individual cardiovascular risk, will be determined by applanation tonometry using SphygmoCorVx technology (AtCor Medical). PWV is an index of the overall stiffness of a vascular segment between measurement sites 59. Thus, while carotid-femoral PWV is an index of the overall stiffness of proximal (central) arteries, the overall stiffness of peripheral arteries contributes relatively more to carotid-radial PWV.


Biospecimen Retention:   Samples Without DNA
serum and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598674


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
American Society of Nephrology
Investigators
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Principal Investigator: Marie-Carmelle Elie, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02598674    
Other Study ID Numbers: IRB201500264
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
acute kidney injury
Additional relevant MeSH terms:
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Sepsis
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes