NCT05285371

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

Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dehydration in Children
• Fluid Therapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urinalysis (UA)	Urinalysis will be performed twice daily starting on Postoperative Day 0.
DIAGNOSTIC_TEST	Complete Metabolic Panel (CMP)	A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
DIAGNOSTIC_TEST	Glucose Stick Test (d-Stick)	A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
OTHER	Medical Chart Review	A medical chart review will be performed for all subjects enrolled.

Timeline

• Start date: 2022-02-22
• Primary completion: 2023-04-19
• Completion: 2024-08-01
• First posted: 2022-03-17
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study