NCT02599844|Withdrawn
Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults
IMPRESS-YA
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults - IMPRESS YA
Loading search results
IMPRESS-YA
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults - IMPRESS YA
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
December 2015
Actual (reported)Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2015
Actual (reported)November 9, 2015
Actual (reported)December 2015
Actual (reported)February 1, 2020
Actual (reported)February 1, 2020
Actual (reported)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.
24 hour ambulatory Blood Pressure
24 hours
Peripheral Arterial Tonometry
24 hours
Pulse Wave Velocity
24 hours
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).
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)
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.
serum and urine
Marie-Carmelle Elie, MD
University of Florida
0 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2015
First Posted
November 9, 2015
Study Start
December 2015
Actual (reported)Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)Last Updated
March 27, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: