- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599844
Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults (IMPRESS-YA)
March 26, 2020 updated by: University of Florida
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults - IMPRESS YA
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.
Study Overview
Status
Withdrawn
Detailed 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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Intent to contact and enroll subjects with severe sepsis related AKI subjects without sepsis related AKI and a sample of age and sex-matched healthy controls.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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).
|
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
Other Names:
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.
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
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.
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
|
Sepsis without AKI
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).
|
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
Other Names:
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.
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
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.
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 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.
|
Day 2
|
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.
|
Day 2
|
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.
|
Day 2
|
Microalbuminuria will be measured in the urine
Time Frame: Day 2
|
The level of albumin protein produced by microalbuminuria can be detected by special albumin-specific urine dipsticks.
A microalbumin urine test determines the presence of the albumin in urine.
In a properly functioning body, albumin is not normally present in urine because it is retained in the bloodstream by the kidneys.
|
Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2015
Primary Completion (ACTUAL)
February 1, 2020
Study Completion (ACTUAL)
February 1, 2020
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
November 4, 2015
First Posted (ESTIMATE)
November 9, 2015
Study Record Updates
Last Update Posted (ACTUAL)
March 27, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500238
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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