NCT02372721|Withdrawn
Study Stopped
The IRB required this protocol to be split into two different protocols
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
IMPRESS
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The IRB required this protocol to be split into two different protocols
IMPRESS
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 20, 2015
Actual (reported)February 26, 2015
Actual (reported)March 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)March 2015
Actual (reported)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.
Day 2
Hypertension
24 hours
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.
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.
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.
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
serum and urine
Marie-Carmelle Elie, MD
University of Florida
0 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2015
First Posted
February 26, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
November 2, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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