Cystatin C as a Marker for Detecting Early Renal Dysfunction in a Pediatric Emergency Department (CARING)
|ClinicalTrials.gov Identifier: NCT00462527|
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : June 28, 2011
|Condition or disease||Phase|
|Acute Renal Failure Gastroenteritis Dehydration||Phase 1|
- 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 Na/K 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 benefits/harms 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 patient's health record: We will record patient's 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 Type :||Observational|
|Estimated Enrollment :||464 participants|
|Official Title:||Cystatin C as a Marker for Detecting Early Renal Dysfunction in a Pediatric Emergency Department|
|Study Start Date :||May 2007|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462527
|Department of Pediatric Emergency, Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Ron Tam, MD||Children's Hospital of Eastern Ontario|