Acute Kidney InjuryNCT01416298
Use of Biomarkers to Optimize Fluid Dosing,CRRT Initiation and Discontinuation in Pediatric ICU Patients With AKI
A study testing Continuous Renal Replacement Therapy in people with Acute Kidney Injury and Fluid Overload, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Acute Kidney Injury, Fluid Overload
- What is being tested?
- Continuous Renal Replacement Therapy
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Use of Neutrophil Gelatinase-Associated Lipocalin (NGAL) to Optimize Fluid Dosing, Continuous Renal Replacement Therapy (CRRT) Initiation and Discontinuation in Critically Ill Children With Acute Kidney Injury (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, 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.
Read the detailed description
The specific aims of this proposal are:
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict which critically ill children will ultimately develop significant (>10%) positive ICU fluid accumulation Hypothesis to be tested: Elevated plasma NGAL concentrations (initial plasma threshold > 250 ng/ml) will predict which critically ill children will develop a positive ICU net fluid accumulation of > 10% of ICU admission weight
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict which critically ill children who develop >10-20% ICU fluid overload will recover urine output and kidney function rapidly Hypothesis to be tested: Elevated plasma NGAL concentrations (initial urinary threshold >1 ng/mg Cr ) will predict which critically ill children who develop >10-20% 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 pRIFLE-F
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict kidney function recovery in critically ill children develop >10-20% ICU fluid overload who receive continuous renal replacement therapy Hypothesis to be tested: Decreasing NGAL concentrations will be associated with improvement in urine output and initial resolution of AKI in < 72 hours
This pilot study will be novel in that the investigators will evaluate NGAL levels in near real-time, twice daily to guide clinical decision support in terms of fluid administration effect assessment and CRRT provision in this critically ill pediatric population. Specifically, 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. In addition, the investigators will employ an adaptive study design to readjust the threshold NGAL during the time course of the study if the data suggest adjustment will enrich the data pool.
- Conditions
- Acute Kidney Injury, Fluid Overload
- Being tested
- Continuous Renal Replacement Therapy
- Keywords
- Acute Kidney Injury, Critically ill children, Biomarkers, NGAL, Fluid Overload, Continuous Renal Replacement Therapy (CRRT)
- Medical subject headings
- Acute Kidney Injury, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Renal Replacement TherapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
- Decreasing NGAL will be associated with improvement in urine output and initial resolution of AKI in less than 72 hours
Measured: Day 1 through 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Production of biomarker test discontinued by manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart L Goldstein, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416298
- Sponsor's protocol ID
- Biomarker/CRRT Study
- Status last verified
- Sep 2018
- First submitted
- 26 Jul 2011
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Neutrophil Gelatinase-Associated Lipocalin (NGAL) to Optimize Fluid Dosing, Continuous Renal Replacement Therapy (CRRT) Initiation and Discontinuation in Critically Ill Children With Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT01416298
- Acronym / sponsor ID
- Biomarker/CRRT Study
- Conditions
- Acute Kidney Injury, Fluid Overload
- Keywords
- Acute Kidney Injury, Critically ill children, Biomarkers, NGAL, Fluid Overload, Continuous Renal Replacement Therapy (CRRT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Production of biomarker test discontinued by manufacturer
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aims of this proposal are:
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict which critically ill children will ultimately develop significant (>10%) positive ICU fluid accumulation Hypothesis to be tested: Elevated plasma NGAL concentrations (initial plasma threshold > 250 ng/ml) will predict which critically ill children will develop a positive ICU net fluid accumulation of > 10% of ICU admission weight
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict which critically ill children who develop >10-20% ICU fluid overload will recover urine output and kidney function rapidly Hypothesis to be tested: Elevated plasma NGAL concentrations (initial urinary threshold >1 ng/mg Cr ) will predict which critically ill children who develop >10-20% 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 pRIFLE-F
- Determine if NGAL (POC plasma and confirmatory urine) concentrations can predict kidney function recovery in critically ill children develop >10-20% ICU fluid overload who receive continuous renal replacement therapy Hypothesis to be tested: Decreasing NGAL concentrations will be associated with improvement in urine output and initial resolution of AKI in < 72 hours
This pilot study will be novel in that the investigators will evaluate NGAL levels in near real-time, twice daily to guide clinical decision support in terms of fluid administration effect assessment and CRRT provision in this critically ill pediatric population. Specifically, 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. In addition, the investigators will employ an adaptive study design to readjust the threshold NGAL during the time course of the study if the data suggest adjustment will enrich the data pool.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Renal Replacement TherapyThe 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. | Other | – |
Primary outcome
plasma NGAL
Time frame: Day 1 through 14
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
Results and safety
The study was stopped early (reason given: Production of biomarker test discontinued by manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart L Goldstein, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Renal Replacement Therapy in people with Acute Kidney Injury and Fluid Overload, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Production of biomarker test discontinued by manufacturer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma NGAL (time frame: Day 1 through 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.