Fluid Overload Pulmonary EdemaNCT04215692
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
A study testing Pulmonary ultrasound in people with Fluid Overload Pulmonary Edema and Fluid Overload, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables. Read more about this study
- Who is it for?
- Ages 1 week to 14 years
- Conditions the study is for
- Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated
- What is being tested?
- Pulmonary ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2019to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All pediatric inpatient intensive care unit admissions
- Signed Informed Consent Form
Who cannot join
- Cyanotic congenital heart disease
- Not requiring mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, 20259
About this study
A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.
Read the 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
- Conditions
- Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated, Fluid Overload Without Edema
- Being tested
- Pulmonary ultrasound
- Keywords
- pediatric intensive care, lenght of stay
- Medical subject headings
- Edema, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary ultrasoundDiagnostic test
Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Fluid Therapy | Experimental | Not described Receives: Diagnostic Test: Pulmonary ultrasound |
| Conventional Fluid Therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days that the patient requires care in the ICU
Measured: through study completion, an average of 14 days
Secondary outcomes (3)
Oxygenation Index
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.
Measured: Daily through study completion, an average of 14 days
PaO2/FIO2
Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Measured: Daily through study completion, an average of 14 days
Duration of mechanical ventilation
Days that a patient remains under mechanical ventilation
Measured: through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Nov 2019
- Primary completion15 Dec 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Why it stopped: Recruitment goal not met. Lack of personnel to complete the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Overload Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Responsible party
- Principal investigator, Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215692
- Sponsor's protocol ID
- 2019-R-14
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2019
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04215692
- Acronym / sponsor ID
- 2019-R-14
- Conditions
- Fluid Overload Pulmonary Edema, Fluid Overload, Pneumonia, Ventilator-Associated, Fluid Overload Without Edema
- Keywords
- pediatric intensive care, lenght of stay
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment goal not met. Lack of personnel to complete the trial.
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Fluid Therapy | Experimental | Diagnostic Test: Pulmonary ultrasound |
| Conventional Fluid Therapy | No intervention | – |
Who may qualify
- Ages
- 1 week to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All pediatric inpatient intensive care unit admissions
- Signed Informed Consent Form
Key exclusion criteria (2 listed)
- Cyanotic congenital heart disease
- Not requiring mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary ultrasoundPulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions. | Diagnostic test | Ultrasound Guided Fluid Therapy |
Primary outcome
Length of stay
Time frame: through study completion, an average of 14 days
Number of days that the patient requires care in the ICU
3 secondary outcomes
Oxygenation Index
Time frame: Daily through study completion, an average of 14 days
PaO2/FIO2
Time frame: Daily through study completion, an average of 14 days
Duration of mechanical ventilation
Time frame: through study completion, an average of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No. We are not planning to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary ultrasound in people with Fluid Overload Pulmonary Edema and Fluid Overload, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: through study completion, an average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.