Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

NCT04215692 | Suspended DMC

• 1 other identifier: 2019-R-14
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Conditions

Fluid Overload Pulmonary Edema; Fluid Overload; Pneumonia, Ventilator-Associated; Fluid Overload Without Edema

Keywords

pediatric intensive care; lenght of stay

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Number of days that the patient requires care in the ICU

  through study completion, an average of 14 days

Secondary Outcomes (3)

• Oxygenation Index

  Daily through study completion, an average of 14 days

• PaO2/FIO2

  Daily through study completion, an average of 14 days

• Duration of mechanical ventilation

  through study completion, an average of 14 days

Study Arms (2)

Ultrasound Guided Fluid Therapy

EXPERIMENTAL

Diagnostic Test: Pulmonary ultrasound

Conventional Fluid Therapy

NO INTERVENTION

Interventions

Pulmonary ultrasound DIAGNOSTIC_TEST

Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.

Ultrasound Guided Fluid Therapy

Eligibility Criteria

• Age: 1 Week - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All pediatric inpatient intensive care unit admissions
• Signed Informed Consent Form

You may not qualify if:

• Cyanotic congenital heart disease
• Not requiring mechanical ventilation

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Centenario Hospital Miguel Hidalgo: collaborator

Study Sites (1)

Centenario Hospital Miguel Hidalgo

Aguascalientes, Aguascalientes, 20259, Mexico

Location

MeSH Terms

Conditions

Edema; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 2, 2020
• Study Start: November 1, 2019
• Primary Completion: December 15, 2025
• Study Completion: December 28, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)