Status:
COMPLETED
Boluses of Ringer's in Surgical Kids (BRiSK Study)
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Dehydration in Children
Fluid Therapy
Eligibility:
All Genders
1-21 years
Phase:
EARLY_PHASE1
Brief Summary
Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar....
Detailed Description
Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday \& Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. Th...
Eligibility Criteria
Inclusion
- Males or females age 12 months to 21 years.
- Weight \>= 8 kg.
- Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
- Patients admitted to a regular bed following surgery.
- Patients who will be inpatient for approximately 4-8 days postoperatively.
- Parental/guardian permission (informed consent).
Exclusion
- Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
- Patients prescribed insulin.
- Patients receiving parenteral nutrition.
- Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
- Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
- Patients with any form of hypersensitivity to the study fluids.
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- Serum Sodium \<130 or \>145 mmol/L
- Serum Potassium \<3.0 or \>5.0 mEq/L
- Serum Chloride \<90 or \>110 mEq/L
- Serum Creatinine ≥ 1.6 mg/dL
- Serum Glucose \<60 or \>180 mg/dL
- Alanine Aminotransferase \>200 U/L
- Total Bilirubin \>12.0 mg/dL
- Pregnant or lactating females.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05285371
Start Date
February 22 2022
End Date
August 1 2024
Last Update
September 19 2024
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104