Boluses of Ringer's in Surgical Kids (BRiSK Study)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution

Conditions
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Dehydration in Children, Fluid Therapy

Intervention / Treatment
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* Diagnostic Test: Urinalysis (UA)
* Diagnostic Test: Complete Metabolic Panel (CMP)
* Diagnostic Test: Glucose Stick Test (d-Stick)
* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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's at 2/3-maintenance rate.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CONT Group<br>CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate. | Diagnostic Test: Urinalysis (UA)<br>* Urinalysis will be performed twice daily starting on Postoperative Day 0.<br>Diagnostic Test: Complete Metabolic Panel (CMP)<br>* A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.<br>Diagnostic Test: Glucose Stick Test (d-Stick)<br>* A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.<br>Other: Medical Chart Review<br>* A medical chart review will be performed for all subjects enrolled.<br>|
| Experimental: BOL Group<br>BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate. | Diagnostic Test: Urinalysis (UA)<br>* Urinalysis will be performed twice daily starting on Postoperative Day 0.<br>Diagnostic Test: Complete Metabolic Panel (CMP)<br>* A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.<br>Diagnostic Test: Glucose Stick Test (d-Stick)<br>* A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.<br>Other: Medical Chart Review<br>* A medical chart review will be performed for all subjects enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Adherence to Study Protocol | Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol. | 4 Days | 
| Feasibility of Measuring and Collecting Urine Output | Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase. | 4 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis | Feasibility will be determined if at least 70% of enrolled study participants have at least 75% of study laboratory tests collected and recorded during the study treatment phase. | 4 Days | 
| Feasibility of Randomization | Feasibility will be determined if at least 85% of eligible study participants are subsequently enrolled, consented, and randomized during their pre-operative phase of care. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydration, Fluids, Lactated Ringer's, Hyponatremia, Dehydration, Post Operative, Pediatrics, Children, Intravenous Fluid Therapy