Acute Kidney InjuryIMPRESSNCT02372721
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
An observational study of Acute Kidney Injury and Chronic Kidney Disease, run by University of Florida.
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 5 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2015
- 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 5 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: We intend to contact and enroll patients with severe sepsis related AKI patients without sepsis related AKI and a sample of age and sex-matched healthy controls
Who may be able to join
- For non-acute kidney injury (AKI) sepsis patients:
- Hospitalization with a diagnosis of sepsis from 1998-2014
- Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for AKI during incident admission.
- Participation in cognitive survey study with completion of survey
- For sepsis related AKI patients:
- Hospitalization with a diagnosis of sepsis from 1998-2014
Show all 11Show fewer
- Need for renal replacement therapy (RRT)
- Severe AKI as defined by the pRIFLE criteria (estimated CrCl (eCrCl) decrease by 50%, eCrCl <60 ml/min/1.73 m2, or a urine output <0.5 ml/kg/h for 24 h or anuric for 12 h) during the sepsis admission
- Participation in cognitive survey study with completion of survey
- For healthy control patients:
- 1. Identified from the neurology service who are scheduled for MRI with gadolinium as part of their clinical care
Who cannot join
- For all patients:
- Known pre-existing chronic kidney disease (CKD) as defined by history of kidney transplant or long-term dialysis
- Age greater than 18 years at the time of sepsis admission
- AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
- Pregnancy at the time of enrollment
- Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment.
Show all 10Show fewer
- For healthy control patients:
- Chronic kidney injury (CKD)
- History of acute kidney injury
- History of any chronic illnesses (e.g. cancer)
About this study
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 three-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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis with Severe AKI | History of a pediatric admission with sepsis related AKI which lead to classification of "injury" or "failure". This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. | |
| Sepsis without AKI | History of a pediatric admission with sepsis which lead to no classification of AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. | |
| Control | No history of an admission for AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Kidney Disease
Obtaining preliminary estimates of glomerular function, renal plasma flow, proteinuria, cystatin C and microalbuminuria in children with and without a history of acute kidney injury in order to assess the presence of chronic kidney disease.
Measured: Day 2
Secondary outcomes (1)
Hypertension
Ambulatory blood pressure (BP) monitoring, peripheral arterial and applanation tonometry will be performed. A subject will be considered hypertensive if systolic and/or diastolic blood pressure is >95th percentile for sex, age, and height.
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 posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: The IRB required this protocol to be split into two different protocols
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
- Responsible party
- Sponsor
- Investigators
- Marie-Carmelle Elie, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372721
- Sponsor's protocol ID
- IRB201400925
- Acronym
- IMPRESS
- Status last verified
- Oct 2015
- First submitted
- 20 Feb 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. 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
- ClinicalTrials.gov ID
- NCT02372721
- Acronym / sponsor ID
- IMPRESS / IRB201400925
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- Keywords
- acute kidney injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The IRB required this protocol to be split into two different protocols
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Feb 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 three-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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis with Severe AKI | – | –History of a pediatric admission with sepsis related AKI which lead to classification of "injury" or "failure". This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. |
| Sepsis without AKI | – | –History of a pediatric admission with sepsis which lead to no classification of AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. |
| Control | – | –No history of an admission for AKI. This group will have urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by cardiovascular assessments using blood pressure monitoring, peripheral arterial and applanation tonometry. |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We intend to contact and enroll patients with severe sepsis related AKI patients without sepsis related AKI and a sample of age and sex-matched healthy controls
Key inclusion criteria (11 listed)
- Hospitalization with a diagnosis of sepsis from 1998-2014
- Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for AKI during incident admission.
- Participation in cognitive survey study with completion of survey
- Hospitalization with a diagnosis of sepsis from 1998-2014
- Need for renal replacement therapy (RRT)
Key exclusion criteria (10 listed)
- Known pre-existing chronic kidney disease (CKD) as defined by history of kidney transplant or long-term dialysis
- Age greater than 18 years at the time of sepsis admission
- AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
- Pregnancy at the time of enrollment
- Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Kidney Disease
Time frame: Day 2
Obtaining preliminary estimates of glomerular function, renal plasma flow, proteinuria, cystatin C and microalbuminuria in children with and without a history of acute kidney injury in order to assess the presence of chronic kidney disease.
1 secondary outcome
Hypertension
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 2 Nov 2015.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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
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.
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 11 inclusion and 10 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Chronic Kidney Disease (time frame: Day 2). 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 2 Nov 2015.