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Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis (IMPRESS)

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ClinicalTrials.gov Identifier: NCT02372721
Recruitment Status : Withdrawn (The IRB required this protocol to be split into two different protocols)
First Posted : February 26, 2015
Last Update Posted : November 1, 2015
Sponsor:
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
Acute Kidney Injury Chronic Kidney Disease Hypertension

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
Study Start Date : March 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hypertension [ Time Frame: 24 hours ]
    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.


Biospecimen Retention:   Samples Without DNA
serum and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

For non-acute kidney injury (AKI) sepsis patients:

  1. Hospitalization with a diagnosis of sepsis from 1998-2014
  2. Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for AKI during incident admission.
  3. Participation in cognitive survey study with completion of survey

For sepsis related AKI patients:

  1. Hospitalization with a diagnosis of sepsis from 1998-2014
  2. Need for renal replacement therapy (RRT)
  3. 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
  4. 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

Exclusion Criteria:

For all patients:

  1. Known pre-existing chronic kidney disease (CKD) as defined by history of kidney transplant or long-term dialysis
  2. Age greater than 18 years at the time of sepsis admission
  3. AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
  4. Pregnancy at the time of enrollment
  5. Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment.

For healthy control patients:

  1. Chronic kidney injury (CKD)
  2. History of acute kidney injury
  3. History of any chronic illnesses (e.g. cancer)

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): NCT02372721


Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Marie-Carmelle Elie, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02372721    
Other Study ID Numbers: IRB201400925
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Keywords provided by University of Florida:
acute kidney injury
Additional relevant MeSH terms:
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Sepsis
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Wounds and Injuries
Urologic Diseases
Renal Insufficiency
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes