Back to resultsBoluses of Ringer's in Surgical Kids (BRiSK Study) (BRiSK)
Primary Purpose
Dehydration in Children, Fluid Therapy
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Urinalysis (UA)
Complete Metabolic Panel (CMP)
Glucose Stick Test (d-Stick)
Medical Chart Review
Sponsored by
About this trial
This is an interventional treatment trial for Dehydration in Children focused on measuring Hydration, Fluids, Lactated Ringer's, Hyponatremia, Dehydration, Post Operative, Pediatrics, Children, Intravenous Fluid Therapy
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
CONT Group
BOL Group
Arm Description
CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05285371
First Posted
March 9, 2022
Last Updated
October 3, 2023
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT05285371
Brief Title
Boluses of Ringer's in Surgical Kids (BRiSK Study)
Acronym
BRiSK
Official Title
Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration in Children, Fluid Therapy
Keywords
Hydration, Fluids, Lactated Ringer's, Hyponatremia, Dehydration, Post Operative, Pediatrics, Children, Intravenous Fluid Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONT Group
Arm Type
Placebo Comparator
Arm Description
CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
Arm Title
BOL Group
Arm Type
Experimental
Arm Description
BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinalysis (UA)
Intervention Description
Urinalysis will be performed twice daily starting on Postoperative Day 0.
Intervention Type
Diagnostic Test
Intervention Name(s)
Complete Metabolic Panel (CMP)
Intervention Description
A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
Intervention Type
Diagnostic Test
Intervention Name(s)
Glucose Stick Test (d-Stick)
Intervention Description
A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
Intervention Type
Other
Intervention Name(s)
Medical Chart Review
Intervention Description
A medical chart review will be performed for all subjects enrolled.
Primary Outcome Measure Information:
Title
Fluid Adherence to Study Protocol
Description
Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.
Time Frame
4 Days
Title
Feasibility of Measuring and Collecting Urine Output
Description
Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.
Time Frame
4 Days
Secondary Outcome Measure Information:
Title
Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis
Description
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.
Time Frame
4 Days
Title
Feasibility of Randomization
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mattei, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Boluses of Ringer's in Surgical Kids (BRiSK Study)
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