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Clinical Trial Details

Trial ID: L0699
Source ID: NCT02599844
Associated Drug: Iodohippurate
Title: Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults
Acronym: IMPRESS-YA
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Acute Kidney Injury|Chronic Kidney Disease|Hypertension
Interventions: DRUG: Iodohippurate|PROCEDURE: 24 hour ambulatory Blood Pressure|PROCEDURE: Peripheral Arterial Tonometry|PROCEDURE: Pulse Wave Velocity|DRUG: Gadolinium
Outcome Measures: Primary: Glomerular Function Rate (GFR) filtration, 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, 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, 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, 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, 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: 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., 24 hours|Peripheral Arterial Tonometry, The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation., 24 hours|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., 24 hours
Sponsor/Collaborators: Sponsor: University of Florida | Collaborators: American Society of Nephrology
Gender: ALL
Age: ADULT
Phases:
Enrollment: 0
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2015-12
Completion Date: 2020-02-01
Results First Posted:
Last Update Posted: 2020-03-27
Locations:
URL: https://clinicaltrials.gov/show/NCT02599844