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

Stopped early · Not applicable

Conditions studied: Acute Kidney Injury, Fluid Overload

In brief

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.

Key facts

Study ID

NCT01416298

Run by

Children's Hospital Medical Center, Cincinnati

People needed

39

Starts

2011-08-01

Expected to finish

2015-12-01

Last updated by the study team

2018-09-20

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 1-25 years old
• Must weigh at least 20kg
• Receiving mechanical ventilation
• Receiving at least 1 vasoactive medication: dopamine (dose greater then 5 micrograms/kg/min), Dobutamine, Epinephrine, Norepinephrine or Vasopressin

You may not qualify if…

• History of End Stage Renal Disease, on Dialysis
• Immediately post renal transplant
• Within 96 hours of Cardiopulmonary Bypass Surgery
• Weight less than 20 kg Patient with a DNR order, "do not escalate care" order, or life expectancy of less than 1 week.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.