Clinical trial NCT05285371: Boluses of Ringer's in Surgical Kids (BRiSK Study)
Official title: Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dehydration in Children
Fluid Therapy
Keywords: Hydration
Fluids
Lactated Ringer's
Hyponatremia
Dehydration
Post Operative
Pediatrics
Children
Intravenous Fluid Therapy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomized into one of two groups - Continuous (CONT) or Bolus (BOL).

CONT group will receive traditional continuous D50.45% NaCl + 20 mEq/L KCl solution at 2/3 maintenance rate.

BOL group will receive intravenous boluses of Lactated Ringer\&#39;s at 2/3-maintenance rate.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Males or females age 12 months to 21 years.
2. Weight \>= 8 kg.
3. 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.
4. Patients admitted to a regular bed following surgery.
5. Patients who will be inpatient for approximately 4-8 days postoperatively.
6. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
2. Patients prescribed insulin.
3. Patients receiving parenteral nutrition.
4. Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
5. Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
6. Patients with any form of hypersensitivity to the study fluids.
7. 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
8. Pregnant or lactating females.
9. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Fluid Adherence to Study Protocol
timeFrame: 4 Days
measure: Feasibility of Measuring and Collecting Urine Output
timeFrame: 4 Days
Secondary outcomes:
measure: Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis
timeFrame: 4 Days
measure: Feasibility of Randomization
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Peter Mattei, MD
role: PRINCIPAL_INVESTIGATOR
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