Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

NCT02372721 | Withdrawn

• 1 other identifier: IRB201400925
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury; Chronic Kidney Disease; Hypertension

Keywords

acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hypertension

  24 hours

Study Arms (3)

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.

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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
• 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:
• \. Identified from the neurology service who are scheduled for MRI with gadolinium as part of their clinical care

You may not qualify if:

• 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.
• For healthy control patients:
• Chronic kidney injury (CKD)
• History of acute kidney injury
• History of any chronic illnesses (e.g. cancer)

Sponsors & Collaborators

• University of Florida: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and urine

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marie-Carmelle Elie, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10