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

NCT01416298 | Terminated

• 1 other identifier: Biomarker/CRRT Study
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury; Fluid Overload

Keywords

Acute Kidney Injury; Critically ill children; Biomarkers; NGAL; Fluid Overload; Continuous Renal Replacement Therapy (CRRT)

Outcome Measures

Primary Outcomes (1)

• plasma NGAL

  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 AKI in less than 72 hours

  Day 1 through 14

Interventions

Continuous Renal Replacement Therapy OTHER

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.

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Edema

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Stuart L Goldstein, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

US (1)