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

September 12, 2024 updated by: Children's Hospital of Philadelphia

Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CONT Group
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)
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.
Experimental: BOL Group
BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 Days
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.
4 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 Days
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Peter Mattei, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

April 19, 2023

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-019180

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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