Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults (IMPRESS-YA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02599844
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : February 7, 2019
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 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults - IMPRESS YA
Study Start Date : December 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
  • Magnevist Gadolinium (GD)
  • Glomerular Function Rate (GFR) filtration

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).
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
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
Other Names:
  • Magnevist 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.

  5. 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.


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT02599844


Contacts
Layout table for location contacts
Contact: Marie-Carmelle Elie, MD 352-265-5911

Locations
Layout table for location information
United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32608
Contact: Marie-Carmelle Elie, MD    352-265-5911    elie@ufl.edu   
Contact: Kristy L Radeker, MSM    352-733-1462    kristylp@ufl.edu   
Principal Investigator: Marie-Carmelle Elie, MD         
Sponsors and Collaborators
University of Florida
American Society of Nephrology
Investigators
Layout table for investigator information
Principal Investigator: Marie-Carmelle Elie, MD University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02599844     History of Changes
Other Study ID Numbers: IRB201500238
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by University of Florida:
acute kidney injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Sepsis
Urologic Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes