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Use of Biomarkers to Optimize Fluid Dosing,CRRT Initiation and Discontinuation in Pediatric ICU Patients With AKI

NCT01416298 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-09-20

No results posted yet for this study

Summary

Acute Kidney Injury (AKI) is a common clinical problem defined by an abrupt (\< 48 hour) increase in serum creatinine (SCr) resulting from an injury or insult that causes a functional or structural change in the kidney. Despite significant advancements in the care of the critically ill child, mortality rates observed in critically ill children who develop AKI have not improved. The investigators have shown even "small" increases in SCr, which is the standard kidney function marker, are associated with increased child mortality, even when outcome was controlled for significant patient co-morbidity. Furthermore, the investigators have also shown that the amount of fluid accumulation observed in critically ill children with AKI is independently associated with mortality suggesting that earlier dialysis may improve survival. However, the investigators also do not want to dialyze patients who don't ultimately need dialysis, as it is an invasive procedure. The data cited above highlight the need not only to detect AKI early, but also predict it severity in order to optimize clinical decision making with respect to fluid administration and dialysis initiation. While substantial research has been expended to validate NGAL as an early marker of AKI, it has not been studied in the context of clinical decision support to guide a therapeutic intervention. The investigators hypothesize that NGAL levels can be used to determine predict which critically ill children will develop severe and prolonged AKI with substantial volume overload, thereby providing the clinician with a diagnostic tool to guide CRRT initiation.

Conditions

Interventions

OTHER

Continuous Renal Replacement Therapy

The investigators will use the NGAL data daily to 1) drive initiation of CRRT in children with elevated NGAL and \> 10-20% fluid overload and 2) drive CRRT discontinuation in patients with decreasing NGAL concentrations. All members of the Critical Care Medicine and Nephrology divisions have agreed that initiation of CRRT within 24-48 hours of a patient reaching \>10% fluid overload is clinically acceptable, and that often the decision to start CRRT has been arbitrary in the past, based on physician bias or preference. All members agree that the current standard of 24-48 hours after \>10% is achieved is acceptable and now will be put into standard clinical practice.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Stuart L Goldstein, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416298 on ClinicalTrials.gov