CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 70 enrolled
Drug / intervention
Urinalysis (UA) +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05285371
NCT05285371Early Ph 1Completed

Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution

Children's Hospital of Philadelphia·interventional·Posted Mar 17, 2022·Updated Sep 19, 2024

In Brief

A Early Phase 1 clinical trial evaluating Urinalysis (UA), Complete Metabolic Panel (CMP), and 2 other interventions for Dehydration in Children and Fluid Therapy. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2023202420252026
First PostedMar 17, 2022
Enrollment StartFeb 22, 2022
Primary CompletionApr 19, 2023
Study CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.3 years ago

Interventions

Urinalysis (UA)other

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

Complete Metabolic Panel (CMP)other

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

Glucose Stick Test (d-Stick)other

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 Reviewother

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