Severe Sepsis in Children - IMPRESS-C

Hypertension Clinical Trial

— IMPRESS-C  

Official title:

Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02598674
• Other study ID #: IRB201500264
• Status: Withdrawn
• Start date: October 2019
• Est. completion date: September 2021

Study information

• Verified date: December 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sepsis

Intervention

Drug:
• Iodohippurate
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Society of Nephrology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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
Primary	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
Primary	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
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
Secondary	Peripheral Arterial Tonometry	The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.	24 hours
Secondary	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