Respiratory InfectionPhase 2/3LESSERNCT02989051
Fluid Restriction Keeps Children Dry
A Phase 2/3 study testing Restrictive fluid regimen and Liberal fluid regimen in people with Respiratory Infection and Fluid Overload, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Fluid overload is a common complication in children who are admitted to the pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause for admission to the PICU and forms an uniform group with a single organ failure. Read more about this study
- Who is it for?
- Ages 1 week to 10 years
- Conditions the study is for
- Respiratory Infection, Fluid Overload, Critical Illness
- What is being tested?
- Restrictive fluid regimen and Liberal fluid regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Nov 2018
- Phase
- Phase 2/3
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent by parents or legal caretakers
- Admitted to the PICU of the Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands
- Intubated and mechanically ventilated, with an anticipated duration of mechanical ventilation of at least 72 hours at enrolment (as judged by investigator or pediatrician on duty)
- Patients with an acute infectious lung disease, including (suspected) viral, bacterial or fungal infection
Who cannot join
- Patients in need of a particular fluid regimen (either restrictive or liberal) due to their medical history (e.g. cardiovascular disease and/or congenital (cyanotic) heart disease)
- Use of previous and/or maintenance diuretic treatment
- Ongoing (fluid) resuscitation on admission
- Acute kidney injury with need for renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam
Job BM van Woensel, Professor, 0031-20-566579, ic.kinderen@amc.nl
Sarah A Ingelse, MD, 0031-20-5665675, s.a.ingelse@amc.nl
About this study
Official title: Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?
Rationale: Fluid overload is a common complication in children who are admitted to the pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause for admission to the PICU and forms an uniform group with a single organ failure. In these critically ill children, fluid overload is associated with adverse outcome. Restricting the volume of fluids already in an early stage of ICU admission may prevent fluid overload during mechanical ventilation and thus improve clinical outcome. However, at the same time fluid restriction may interfere with appropriate energy and macronutrient intake that is needed for recovery.
Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive fluid management protocol and investigate its effect on the occurrence of fluid overload in mechanically ventilated children with acute infectious lung disease.
Read more
Study design: Single-center prospective randomized feasibility and pilot study in preparation of a multi-center randomized controlled trial (RCT).
Study population: Mechanically ventilated children with (suspicion of) acute infectious lung disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital, Academic Medical Center, Amsterdam.
Intervention: Patients receive either liberal (control group) or a restrictive (experimental group) fluid treatment, while ensuring appropriate caloric intake.
Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as energy and protein intake are studied.
Both fluid management protocols reflect a variant of current clinical practice, hence will not provide extra burden or risk to patients included in the study. Patients will be randomized to either of the fluid protocol arms on admission to the PICU (at start of mechanical ventilation). Patients included in the restrictive fluid treatment arm might have direct benefit from the study if indeed fluid overload is less common in this group.
- Being tested
- Restrictive fluid regimen, Liberal fluid regimen
- Medical subject headings
- Respiratory Tract Infections, Edema, Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive fluid regimenOther
In this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child).
Liberal fluid regimenOther
This is considered current standard clinical treatment, wherein patients will receive a fluid regimen of >85% of normal fluid recommendations (for a healthy child).
| Study group | Role | What they receive |
|---|---|---|
| Restrictive fluid treatment | Experimental | Restrictive fluid regimen Receives: Other: Restrictive fluid regimen |
| Liberal fluid treatment | Active comparator | This is seen as current standard clinical treatment, wherein patients will receive a more liberal fluid regimen. Receives: Other: Liberal fluid regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fluid balance
Measured: First week of mechanical ventilation
Body weight
Measured: First week of mechanical ventilation
Secondary outcomes (3)
Duration of mechanical ventilation
Measured: Through study completion, an average of 1 week
Oxygenation indices
Measured: Through study completion, an average of 1 week
Mortality
Measured: Up to 90 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.B.M. van Woensel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989051
- Sponsor's protocol ID
- 2016_096
- Acronym
- LESSER
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingelse SA, Geukers VG, Dijsselhof ME, Lemson J, Bem RA, van Woensel JB. Less Is More?-A Feasibility Study of Fluid Strategy in Critically Ill Children With Acute Respiratory Tract Infection. Front Pediatr. 2019 Dec 10;7:496. doi: 10.3389/fped.2019.00496. eCollection 2019.
PubMed 31921715
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?
- ClinicalTrials.gov ID
- NCT02989051
- Acronym / sponsor ID
- LESSER / 2016_096
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- 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.
Rationale: Fluid overload is a common complication in children who are admitted to the pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause for admission to the PICU and forms an uniform group with a single organ failure. In these critically ill children, fluid overload is associated with adverse outcome. Restricting the volume of fluids already in an early stage of ICU admission may prevent fluid overload during mechanical ventilation and thus improve clinical outcome. However, at the same time fluid restriction may interfere with appropriate energy and macronutrient intake that is needed for recovery.
Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive fluid management protocol and investigate its effect on the occurrence of fluid overload in mechanically ventilated children with acute infectious lung disease.
Study design: Single-center prospective randomized feasibility and pilot study in preparation of a multi-center randomized controlled trial (RCT).
Study population: Mechanically ventilated children with (suspicion of) acute infectious lung disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital, Academic Medical Center, Amsterdam.
Intervention: Patients receive either liberal (control group) or a restrictive (experimental group) fluid treatment, while ensuring appropriate caloric intake.
Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as energy and protein intake are studied.
Both fluid management protocols reflect a variant of current clinical practice, hence will not provide extra burden or risk to patients included in the study. Patients will be randomized to either of the fluid protocol arms on admission to the PICU (at start of mechanical ventilation). Patients included in the restrictive fluid treatment arm might have direct benefit from the study if indeed fluid overload is less common in this group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive fluid treatment | Experimental | Other: Restrictive fluid regimenRestrictive fluid regimen |
| Liberal fluid treatment | Active comparator | Other: Liberal fluid regimenThis is seen as current standard clinical treatment, wherein patients will receive a more liberal fluid regimen. |
Who may qualify
- Ages
- 1 week to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Signed informed consent by parents or legal caretakers
- Admitted to the PICU of the Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands
- Intubated and mechanically ventilated, with an anticipated duration of mechanical ventilation of at least 72 hours at enrolment (as judged by investigator or pediatrician on duty)
- Patients with an acute infectious lung disease, including (suspected) viral, bacterial or fungal infection
Key exclusion criteria (4 listed)
- Patients in need of a particular fluid regimen (either restrictive or liberal) due to their medical history (e.g. cardiovascular disease and/or congenital (cyanotic) heart disease)
- Use of previous and/or maintenance diuretic treatment
- Ongoing (fluid) resuscitation on admission
- Acute kidney injury with need for renal replacement therapy
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 |
|---|---|---|
| Restrictive fluid regimenIn this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child). | Other | Restrictive fluid treatment |
| Liberal fluid regimenThis is considered current standard clinical treatment, wherein patients will receive a fluid regimen of >85% of normal fluid recommendations (for a healthy child). | Other | Liberal fluid treatment |
Primary outcome
Cumulative fluid balance
Time frame: First week of mechanical ventilation
Body weight
Time frame: First week of mechanical ventilation
3 secondary outcomes
Duration of mechanical ventilation
Time frame: Through study completion, an average of 1 week
Oxygenation indices
Time frame: Through study completion, an average of 1 week
Mortality
Time frame: Up to 90 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Derived from this study: PubMed 31921715Ingelse SA, Geukers VG, Dijsselhof ME, Lemson J, Bem RA, van Woensel JB. Less Is More?-A Feasibility Study of Fluid Strategy in Critically Ill Children With Acute Respiratory Tract Infection. Front Pediatr. 2019 Dec 10;7:496. doi: 10.3389/fped.2019.00496. eCollection 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Restrictive fluid regimen and Liberal fluid regimen in people with Respiratory Infection and Fluid Overload, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. 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 Netherlands. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Job BM van Woensel, Professor (0031-20-5665769, ic.kinderen@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance (time frame: First week of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989051, which also lists 1 linked publication.
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 12 Dec 2016.