Skip to main content
OpenTrials
Completed

NCT Number: NCT05285371

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urinalysis (UA)

Diagnostic Test

Urinalysis will be performed twice daily starting on Postoperative Day 0.

Complete Metabolic Panel (CMP)

Diagnostic Test

A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.

Glucose Stick Test (d-Stick)

Diagnostic Test

A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.

medical chart review

Other

A medical chart review will be performed for all subjects enrolled.

Primary outcomes

  1. 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.

  2. 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

  1. Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis

    Time frame: 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.

  2. Feasibility of Randomization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution

Acronym: BRiSK

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.