Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

NCT ID: NCT02372721

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-03-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Carmelle Elie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

IRB201400925

Identifier Type: -

Identifier Source: org_study_id