Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

Hypertension Clinical Trial

— IMPRESS  

Official title:

Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02372721
• Other study ID #: IRB201400925
• Status: Withdrawn
• Phase: N/A
• First received: February 20, 2015
• Last updated: October 29, 2015
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 24 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	24 hours	No