Clinical trial NCT02989051: Fluid Restriction Keeps Children Dry
Official title: Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Respiratory Infection
Fluid Overload
Critical Illness
Respiratory Insufficiency
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cumulative fluid balance
timeFrame: First week of mechanical ventilation
measure: Body weight
timeFrame: First week of mechanical ventilation
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Through study completion, an average of 1 week
measure: Oxygenation indices
timeFrame: Through study completion, an average of 1 week
measure: Mortality
timeFrame: Up to 90 days after admission
Other outcomes:
measure: In- and exclusion rate
timeFrame: Through study completion, an average of 1 week
measure: Adherence to treatment arms
timeFrame: Through study completion, an average of 1 week
measure: Need for fluid bolus
timeFrame: Through study completion, an average of 1 week
measure: Need for diuretics
timeFrame: Through study completion, an average of 1 week
measure: Need for vasopressors or inotropic drugs
timeFrame: Through study completion, an average of 1 week
measure: Energy and protein intake
timeFrame: Through study completion, an average of 1 week
measure: Gastrointestinal complaints
timeFrame: Through study completion, an average of 1 week
measure: Hemodynamic indices
timeFrame: Through study completion, an average of 1 week
measure: Occurrence of electrolyte imbalances
timeFrame: Through study completion, an average of 1 week
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
citation: 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.