<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989051</url>
  </required_header>
  <id_info>
    <org_study_id>2016_096</org_study_id>
    <nct_id>NCT02989051</nct_id>
  </id_info>
  <brief_title>Fluid Restriction Keeps Children Dry</brief_title>
  <acronym>LESSER</acronym>
  <official_title>Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Fluid overload is a common complication in children who are admitted to the&#xD;
      pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause&#xD;
      for admission to the PICU and forms an uniform group with a single organ failure. In these&#xD;
      critically ill children, fluid overload is associated with adverse outcome. Restricting the&#xD;
      volume of fluids already in an early stage of ICU admission may prevent fluid overload during&#xD;
      mechanical ventilation and thus improve clinical outcome. However, at the same time fluid&#xD;
      restriction may interfere with appropriate energy and macronutrient intake that is needed for&#xD;
      recovery.&#xD;
&#xD;
      Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive&#xD;
      fluid management protocol and investigate its effect on the occurrence of fluid overload in&#xD;
      mechanically ventilated children with acute infectious lung disease.&#xD;
&#xD;
      Study design: Single-center prospective randomized feasibility and pilot study in preparation&#xD;
      of a multi-center randomized controlled trial (RCT).&#xD;
&#xD;
      Study population: Mechanically ventilated children with (suspicion of) acute infectious lung&#xD;
      disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital,&#xD;
      Academic Medical Center, Amsterdam.&#xD;
&#xD;
      Intervention: Patients receive either liberal (control group) or a restrictive (experimental&#xD;
      group) fluid treatment, while ensuring appropriate caloric intake.&#xD;
&#xD;
      Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body&#xD;
      weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of&#xD;
      the larger multi-center RCT) include: mortality, duration of mechanical ventilation and&#xD;
      oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to&#xD;
      treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as&#xD;
      energy and protein intake are studied.&#xD;
&#xD;
      Both fluid management protocols reflect a variant of current clinical practice, hence will&#xD;
      not provide extra burden or risk to patients included in the study. Patients will be&#xD;
      randomized to either of the fluid protocol arms on admission to the PICU (at start of&#xD;
      mechanical ventilation). Patients included in the restrictive fluid treatment arm might have&#xD;
      direct benefit from the study if indeed fluid overload is less common in this group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative fluid balance</measure>
    <time_frame>First week of mechanical ventilation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>First week of mechanical ventilation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation indices</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 90 days after admission</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>In- and exclusion rate</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to treatment arms</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Need for fluid bolus</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Need for diuretics</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Need for vasopressors or inotropic drugs</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Energy and protein intake</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gastrointestinal complaints</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hemodynamic indices</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of electrolyte imbalances</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Respiratory Infection</condition>
  <condition>Fluid Overload</condition>
  <condition>Critical Illness</condition>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>Restrictive fluid treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restrictive fluid regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liberal fluid treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is seen as current standard clinical treatment, wherein patients will receive a more liberal fluid regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Restrictive fluid regimen</intervention_name>
    <description>In this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child).</description>
    <arm_group_label>Restrictive fluid treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Liberal fluid regimen</intervention_name>
    <description>This is considered current standard clinical treatment, wherein patients will receive a fluid regimen of &gt;85% of normal fluid recommendations (for a healthy child).</description>
    <arm_group_label>Liberal fluid treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent by parents or legal caretakers&#xD;
&#xD;
          -  Admitted to the PICU of the Emma Children's Hospital, Academic Medical Center,&#xD;
             Amsterdam, The Netherlands&#xD;
&#xD;
          -  Intubated and mechanically ventilated, with an anticipated duration of mechanical&#xD;
             ventilation of at least 72 hours at enrolment (as judged by investigator or&#xD;
             pediatrician on duty)&#xD;
&#xD;
          -  Patients with an acute infectious lung disease, including (suspected) viral, bacterial&#xD;
             or fungal infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in need of a particular fluid regimen (either restrictive or liberal) due to&#xD;
             their medical history (e.g. cardiovascular disease and/or congenital (cyanotic) heart&#xD;
             disease)&#xD;
&#xD;
          -  Use of previous and/or maintenance diuretic treatment&#xD;
&#xD;
          -  Ongoing (fluid) resuscitation on admission&#xD;
&#xD;
          -  Acute kidney injury with need for renal replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Job BM van Woensel, Professor</last_name>
    <phone>0031-20-5665769</phone>
    <email>ic.kinderen@amc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah A Ingelse, MD</last_name>
    <phone>0031-20-5665675</phone>
    <email>s.a.ingelse@amc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Job BM van Woensel, Professor</last_name>
      <phone>0031-20-566579</phone>
      <email>ic.kinderen@amc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Sarah A Ingelse, MD</last_name>
      <phone>0031-20-5665675</phone>
      <email>s.a.ingelse@amc.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Sarah A Ingelse, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Reinout A Bem, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Job BM van Woensel, Professor (MD PhD)</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>J.B.M. van Woensel</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989051
org study id: 2016_096
nct id: NCT02989051
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative fluid balance
time frame: First week of mechanical ventilation
measure: Body weight
time frame: First week of mechanical ventilation
measure: Duration of mechanical ventilation
time frame: Through study completion, an average of 1 week
measure: Oxygenation indices
time frame: Through study completion, an average of 1 week
measure: Mortality
time frame: Up to 90 days after admission
measure: In- and exclusion rate
time frame: Through study completion, an average of 1 week
measure: Adherence to treatment arms
time frame: Through study completion, an average of 1 week
measure: Need for fluid bolus
time frame: Through study completion, an average of 1 week
measure: Need for diuretics
time frame: Through study completion, an average of 1 week
measure: Need for vasopressors or inotropic drugs
time frame: Through study completion, an average of 1 week
measure: Energy and protein intake
time frame: Through study completion, an average of 1 week
measure: Gastrointestinal complaints
time frame: Through study completion, an average of 1 week
measure: Hemodynamic indices
time frame: Through study completion, an average of 1 week
measure: Occurrence of electrolyte imbalances
time frame: Through study completion, an average of 1 week
arm group label: Restrictive fluid treatment
arm group type: Experimental
description: Restrictive fluid regimen
arm group label: Liberal fluid treatment
arm group type: Active Comparator
description: This is seen as current standard clinical treatment, wherein patients will receive a more liberal fluid regimen.
intervention type: Other
intervention name: Restrictive fluid regimen
description: In this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child).
arm group label: Restrictive fluid treatment
intervention type: Other
intervention name: Liberal fluid regimen
description: This is considered current standard clinical treatment, wherein patients will receive a fluid regimen of >85% of normal fluid recommendations (for a healthy child).
arm group label: Liberal fluid treatment
criteria: 
gender: All
minimum age: 1 Week
maximum age: 10 Years
healthy volunteers: No
last name: Job BM van Woensel, Professor
phone: 0031-20-5665769
email: ic.kinderen@amc.nl
last name: Sarah A Ingelse, MD
phone: 0031-20-5665675
email: s.a.ingelse@amc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: J.B.M. van Woensel
investigator title: Professor
mesh term: Respiratory Tract Infections
mesh term: Respiratory Insufficiency
mesh term: Critical Illness