Lung Ultrasound-guided Fluid Therapy in Pediatric Intensi... | NCT04215692

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

NCT04215692

Sponsor

Instituto Mexicano del Seguro Social

Status

Suspended

Last Update Posted

May 2, 2025Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

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

Interventions

Pulmonary ultrasound

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment goal not met. Lack of personnel to complete the trial.

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Dec 15, 2025Estimated

Completion Date

Dec 28, 2025Estimated

First Submitted Date

Dec 27, 2019

First Submission Date that Met QC Criteria

Dec 30, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2025

Last Update Posted Date

May 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan Manuel Marquez Romero, Principal Investigator, Instituto Mexicano del Seguro SocialPrincipal Investigator

Lead Sponsor

Instituto Mexicano del Seguro SocialOTHER_GOV

Collaborators

Name	Class
Centenario Hospital Miguel Hidalgo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:

Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound Guided Fluid Therapy	Experimental		Diagnostic Test: Pulmonary ultrasound
Conventional Fluid Therapy	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary ultrasound	Diagnostic Test	Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay	Number of days that the patient requires care in the ICU	through study completion, an average of 14 days

Secondary Outcomes

Measure	Description	Time Frame
Oxygenation Index	Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.	Daily through study completion, an average of 14 days
PaO2/FIO2	Ratio of arterial oxygen partial pressure to fractional inspired oxygen

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pediatric inpatient intensive care unit admissions
Signed Informed Consent Form

Exclusion Criteria:

Cyanotic congenital heart disease
Not requiring mechanical ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Week

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centenario Hospital Miguel Hidalgo		Aguascalientes	Aguascalientes	20259	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

We are not planning to share the data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004487	Edema
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection

Browse Leaves

Not provided

Browse Branches

Not provided