Acute Kidney InjuryIMPRESS-CNCT02598674
Severe Sepsis in Children - IMPRESS-C
An observational study of Acute Kidney Injury and Chronic Kidney Disease, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- What is being tested?
- Iodohippurate, 24 hour ambulatory Blood Pressure and Peripheral Arterial Tonometry
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Contact and enroll subjects with severe sepsis related AKI subjects without sepsis related AKI and a sample of age and sex-matched healthy controls.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
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.
Read the detailed 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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- Being tested
- Iodohippurate, 24 hour ambulatory Blood Pressure, Peripheral Arterial Tonometry, Pulse Wave Velocity, Gadolinium
- Keywords
- acute kidney injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodohippurateDrug
Also called RPF filtration
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
24 hour ambulatory Blood PressureProcedure or surgery
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 TonometryProcedure or surgery
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
Pulse Wave VelocityProcedure or surgery
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.
GadoliniumDrug
Also called Dotarem Gadolinium (GD), Glomerular Function Rate (GFR) filtration
Dotarem Gadolinium (GD)- Gadoterate Meglumine (0.07 to 0.14 mL/kg) will be used to determine GFR.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Iodohippurate; Procedure: 24 hour ambulatory Blood Pressure; Procedure: Peripheral Arterial Tonometry; Procedure: Pulse Wave Velocity; Drug: Gadolinium | |
| Control | This group will not have a history of pediatric admission with sepsis-related Acute Kidney Injury (sAKI). The following test will be performed: urinary and serum studies to measure glomerular filtration rate by using gadolinium, followed by cardiovascular assessments using 24 hour ambulatory blood pressure monitoring, peripheral arterial tonometry and pulse wave velocities (PWV). Receives: Procedure: 24 hour ambulatory Blood Pressure; Procedure: Peripheral Arterial Tonometry; Procedure: Pulse Wave Velocity; Drug: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 2
Secondary outcomes (3)
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.
Measured: 24 hours
Peripheral Arterial Tonometry
The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startOct 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Expired IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Nephrology
- Responsible party
- Sponsor
- Investigators
- Marie-Carmelle Elie, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598674
- Sponsor's protocol ID
- IRB201500264
- Acronym
- IMPRESS-C
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2015
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
- ClinicalTrials.gov ID
- NCT02598674
- Acronym / sponsor ID
- IMPRESS-C / IRB201500264
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- Keywords
- acute kidney injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Expired IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Society of Nephrology
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis with Severe AKI | – | Drug: Iodohippurate, Procedure: 24 hour ambulatory Blood Pressure, Procedure: Peripheral Arterial Tonometry, Procedure: Pulse Wave Velocity, Drug: GadoliniumThis 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). |
| Control | – | Procedure: 24 hour ambulatory Blood Pressure, Procedure: Peripheral Arterial Tonometry, Procedure: Pulse Wave Velocity, Drug: GadoliniumThis group will not have a history of pediatric admission with sepsis-related Acute Kidney Injury (sAKI). The following test will be performed: urinary and serum studies to measure glomerular filtration rate by using gadolinium, followed by cardiovascular assessments using 24 hour ambulatory blood pressure monitoring, peripheral arterial tonometry and pulse wave velocities (PWV). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Contact and enroll subjects with severe sepsis related AKI subjects without sepsis related AKI and a sample of age and sex-matched healthy controls.
Key inclusion criteria (9 listed)
- Ability to assent (age 7-17 at time of participation in the study)
- If taking antihypertensive medication, prescribing practitioner's written approval to participate
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IodohippurateAlso: RPF filtrationAn injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF) | Drug | Sepsis with Severe AKI |
| 24 hour ambulatory Blood PressureAmbulatory 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 or surgery | Control, Sepsis with Severe AKI |
| Peripheral Arterial TonometryThe peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation. | Procedure or surgery | Control, Sepsis with Severe AKI |
| Pulse Wave VelocityCarotid-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. | Procedure or surgery | Control, Sepsis with Severe AKI |
| GadoliniumAlso: Dotarem Gadolinium (GD), Glomerular Function Rate (GFR) filtrationDotarem Gadolinium (GD)- Gadoterate Meglumine (0.07 to 0.14 mL/kg) will be used to determine GFR. | Drug | Control, Sepsis with Severe AKI |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
24 hour ambulatory Blood Pressure
Time frame: 24 hours
Peripheral Arterial Tonometry
Time frame: 24 hours
Pulse wave velocity
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Carmelle Elie, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Kidney Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Function Rate (GFR) filtration (time frame: Day 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.