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

Early Phase 1

Active, not recruiting

• Conditions: Fluid Therapy; Dehydration in Children
• Interventions: Diagnostic Test: Urinalysis (UA); Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Glucose Stick Test (d-Stick); Other: Medical Chart Review

• Registration Number: NCT05285371
• Lead Sponsor: Children's Hospital of Philadelphia

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).

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Primary Completion: 2023-04-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONT Group	Glucose Stick Test (d-Stick)	CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
CONT Group	Medical Chart Review	CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
CONT Group	Urinalysis (UA)	CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
BOL Group	Glucose Stick Test (d-Stick)	BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
CONT Group	Complete Metabolic Panel (CMP)	CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
BOL Group	Urinalysis (UA)	BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
BOL Group	Medical Chart Review	BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
BOL Group	Complete Metabolic Panel (CMP)	BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.

Primary Outcome Measures

Name	Time	Method
Fluid Adherence to Study Protocol	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	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 Outcome Measures

Name	Time	Method
Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis	4 Days	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.
Feasibility of Randomization	Baseline	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States