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NCT01416298 · ClinicalTrials.gov registry record · NA
Use of Biomarkers to Optimize Fluid Dosing,CRRT Initiation and Discontinuation in Pediatric ICU Patients With AKI
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT01416298: Clinical Trial NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01416298 is a NA study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416298, a NA study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
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.
Primary Outcome
Hypotheses:1) Elevated NGAL will predict which critically ill children will develop an ICU net fluid overload (FO) of greater than 10% of ICU adm. wgt. 2)Elevated NGAL will predict which critically ill children who develop greater than 10 to 20% FO will not have an improvement in AKI as determined by an improvement of at least one pRIFLE strata within 24-48 hours of developing pRIFLE "I" or "F." 3\) Decreasing NGAL will be associated with improvement in urine output and initial resolution of A
Interventions
- OTHER Continuous Renal Replacement Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-12 |
| Phase | NA |
Why NCT01416298 stopped before completion
NCT01416298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Continuous Renal Replacement Therapy is the first listed.
NCT01416298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416298 about?
NCT01416298 is a clinical study titled "Use of Biomarkers to Optimize Fluid Dosing,CRRT Initiation and Discontinuation in Pediatric ICU Patients With AKI". 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, mortal...
What is the current status of trial NCT01416298?
This trial is currently terminated. It is a NA study. The enrollment target is 39 participants. The study started on 2011-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01416298?
The interventions under investigation include: Continuous Renal Replacement Therapy (OTHER).
Who is sponsoring clinical trial NCT01416298?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416298's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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