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

NCT05285371 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Dehydration in Children
  • Fluid Therapy

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Peter Mattei, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2023-04-19
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285371 on ClinicalTrials.gov