Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Dehydration in Children
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Fluid Adherence to Study Protocol
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.
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. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Fluid Adherence to Study Protocol
Time Frame: 4 Days
Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.
Feasibility of Measuring and Collecting Urine Output
Time Frame: 4 Days
Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.
Secondary Outcomes
- Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis(4 Days)
- Feasibility of Randomization(Baseline)