Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462527
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2007-04-18
Brief Title:
Cystatin C as a Marker for Detecting Early Renal Dysfunction in a Pediatric Emergency Department
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
Cystatin C as a Marker for Detecting Early Renal Dysfunction in a Pediatric Emergency Department
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARING
Brief Summary:
Acute renal failure ARF is a rare but serious complication of gastroenteritis and dehydration the most common reason for pediatric emergency visits Renal function is determined by the glomerular filtration rate GFR Serum creatinine the current marker of GFR is insensitive and a late marker of ARF Unfortunately gold standard methods for measurement of GFR are impractical in the emergency setting Recently cystatin C CysC was introduced as superior marker for the measurement of GFR particularly in children A single random blood sample allows for accurate determination of GFR in the so-called creatinine-blind range and independent of the body composition There is growing evidence that the determination of serum CysC concentration can detect ARF in adults earlier than serum creatinine or urinary fractional sodium excretion No studies have examined this marker for the early detection of ARF in children at risk We therefore propose a prospective study that compares CysC with other biomarkers of renal dysfunction for the early detection of ARF in children with dehydration due to gastroenteritis Patients with minor trauma and a minimal likelihood of ARF will serve as a control This study may establish CysC as an accurate and cost-effective marker for identifying patients at risk
Detailed Description:
Rationale and hypotheses Acute renal failure is a relatively rare but serious illness in children Early detection is important in preventing life threatening complications that can arise from acute renal failure Presently most methods of determining renal function are either too cumbersome too invasion or too unreliable to be used in children Current evidence has shown that serum cystatin C is more precise and cost-effective in determining renal function Our objective is to compare serum cystatin C with other biomarkers as an early diagnostic detection for renal dysfunction in children with acute renal failure in an emergency setting
Study design and methods This is a prospective double cohort control study to compare the serum creatinine and serum cystatin C in detecting early renal dysfunction in children presenting to the emergency department The study will be conducted in CHEO emergency department A study nurse will identify eligible patients and discuss whether to approach the families with either the bedside nurse or attending physician before meeting them Interested families are than given an explanation of our study Once written consent is obtained a copy will be given to the family Additional tests will than be requested from blood and urine samples of the patients Only patients that already require an intravenous needling are eligible for this study No additional needling is therefore needed as part of this study Urine sample will only be obtained through bad or voiding samples No catheter urine samples will be requested as part of this study
Subject selection Our target population are patients presenting to the CHEO emergency department with the diagnoses of gastroenteritis and dehydration and requiring intravenous rehydration Our control group are patients with traumatic injury requiring conscious sedation and intravenous access We will exclude patients who are known to have underlying kidney diseases renal transplantation thyroid dysfunction chronic systematic steroid uses genitourinary trauma and patients transferred from another hospitals for ongoing assessment and treatment
Specify the number of participants drawn from CHEO and other centres CHEO is the only designated centre for the study 464 patients will be recruited to complete the study 232 in each arm
Delineate the outcomes to be measured and analyzed The primary outcome measures are to compare the sensitivity and the timing of detecting early renal dysfunction using either serum creatinine or serum cystatin C in the paediatric emergency setting Our secondary outcome measures are to compare serum cystatin C to other surrogate renal markers for acute renal failure Other renal markers include calculated Schwartz glomerular filtration rate urine microprotein excretion fractional excretions of sodium and urea serum sodium chloride bicarbonate urine NaK ratio and regular urinalysis Additional analysis will be conducted on the comparison of fractional excretion of urea to fractional excretion of sodium as an earlier marker of dehydration in children
Anticipated benefitsharms and how these will be addressed Only patients who already require needling as part of their hospital care are eligible for the study No additional needling is therefore requested Additional tests will be requested that would otherwise not be part of the routine care of these patients It is therefore possible that a kidney disorder will be identified in a child who was not yet diagnosed with this disease We will discuss this possibility with the family before enrollment of the patient All major abnormalities will be followed by both the attending physician and the principle investigators of the study and appropriate care will apply We do not intervene with the ongoing care of the patients while the patients remain in hospital The study will terminate when patients are discharged from the hospital
Data fields if any to be abstracted from the patients health record We will record patients CHEO medical record number for the purpose of retrieving laboratory data date of birth biometric measurement height weight and sex No other identifiable information will be record on the data sheet No individual information will be used for publication or presentation
Informed consent documents and any advertisement notices must be appended to the application Both English and French versions of the consent forms and information sheets are enclosed with this application
Study design and methods This is a prospective double cohort control study to compare the serum creatinine and serum cystatin C in detecting early renal dysfunction in children presenting to the emergency department The study will be conducted in CHEO emergency department A study nurse will identify eligible patients and discuss whether to approach the families with either the bedside nurse or attending physician before meeting them Interested families are than given an explanation of our study Once written consent is obtained a copy will be given to the family Additional tests will than be requested from blood and urine samples of the patients Only patients that already require an intravenous needling are eligible for this study No additional needling is therefore needed as part of this study Urine sample will only be obtained through bad or voiding samples No catheter urine samples will be requested as part of this study
Subject selection Our target population are patients presenting to the CHEO emergency department with the diagnoses of gastroenteritis and dehydration and requiring intravenous rehydration Our control group are patients with traumatic injury requiring conscious sedation and intravenous access We will exclude patients who are known to have underlying kidney diseases renal transplantation thyroid dysfunction chronic systematic steroid uses genitourinary trauma and patients transferred from another hospitals for ongoing assessment and treatment
Specify the number of participants drawn from CHEO and other centres CHEO is the only designated centre for the study 464 patients will be recruited to complete the study 232 in each arm
Delineate the outcomes to be measured and analyzed The primary outcome measures are to compare the sensitivity and the timing of detecting early renal dysfunction using either serum creatinine or serum cystatin C in the paediatric emergency setting Our secondary outcome measures are to compare serum cystatin C to other surrogate renal markers for acute renal failure Other renal markers include calculated Schwartz glomerular filtration rate urine microprotein excretion fractional excretions of sodium and urea serum sodium chloride bicarbonate urine NaK ratio and regular urinalysis Additional analysis will be conducted on the comparison of fractional excretion of urea to fractional excretion of sodium as an earlier marker of dehydration in children
Anticipated benefitsharms and how these will be addressed Only patients who already require needling as part of their hospital care are eligible for the study No additional needling is therefore requested Additional tests will be requested that would otherwise not be part of the routine care of these patients It is therefore possible that a kidney disorder will be identified in a child who was not yet diagnosed with this disease We will discuss this possibility with the family before enrollment of the patient All major abnormalities will be followed by both the attending physician and the principle investigators of the study and appropriate care will apply We do not intervene with the ongoing care of the patients while the patients remain in hospital The study will terminate when patients are discharged from the hospital
Data fields if any to be abstracted from the patients health record We will record patients CHEO medical record number for the purpose of retrieving laboratory data date of birth biometric measurement height weight and sex No other identifiable information will be record on the data sheet No individual information will be used for publication or presentation
Informed consent documents and any advertisement notices must be appended to the application Both English and French versions of the consent forms and information sheets are enclosed with this application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None