Cystatin C as a Marker for Detecting Early Renal Dysfunction in a Pediatric Emergency Department

NCT00462527 | Completed

• 1 other identifier: PSI 06-49
• Study Type: observational
• Target: 464
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Gastroenteritis; Dehydration

Keywords

Cystatin C; Acute renal failure; Gastroenteritis; Dehydration

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children less than 18 years old who visit the treating pediatric emergency department. Gastro cohort: children suffer acute gastroenteritis with signs of dehydration and require intravenous fluid rehydration Injury cohort: children suffer musculoskeletal injury that require intravenous sedation for the repair

You may qualify if:

• Children less than 18 years old presented with acute gastroenteritis with dehydration, requiring intravenous fluid rehydration

You may not qualify if:

• Children with known renal diseases, renal transplantation, thyroid dysfunction, chronic systematic steroid uses, genitourinary trauma
• Children transferred from another facility for ongoing assessment and treatment
• Children under legal custody
• Voluntary refusal

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Department of Pediatric Emergency, Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Tam RK, Wong H, Plint A, Lepage N, Filler G. Comparison of clinical and biochemical markers of dehydration with the clinical dehydration scale in children: a case comparison trial. BMC Pediatr. 2014 Jun 16;14:149. doi: 10.1186/1471-2431-14-149.

  PMID: 24935348 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Gastroenteritis; Dehydration

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Tam, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 28, 2011

Record last verified: 2007-09

Locations

CA (1)