This research project aims to determine the feasibility of setting up a randomized controlled trial to study the effects of different fluid management protocols on the outcome of mechanically ventilated pediatric patients with acute infectious lung…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Electrolyte and fluid balance conditions
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are (cumulative) fluid balance and body weight during
the first week of mechanical ventilation.
Secondary outcome
The secondary study parameters are in preparation of the larger multi-center
RCT and include:
- Mortality
- Duration of mechanical ventilation
- Oxygenation indices (for which ventilation settings and blood gas analyses
are assessed; taking blood gases is part of standard care in the PICU, no extra
invasive blood punctions will be needed)
To determine the feasibility of the experimental treatment arm, we aim to study:
- In- and exclusion rate
- Adherence to treatment arms
- Need for fluid bolus
- Need for diuretics
- Hemodynamic indices (blood pressure, heart rate, medication)
- Occurrence of electrolyte imbalances (blood gas analyses are part of standard
clinical care, see above)
Background summary
Severe acute infectious lung disease in children often leads to admission to
the PICU for mechanical ventilation. During the course of disease these
patients, both adult and pediatric, are prone for development of fluid
overload. Fluid overload is notoriously known to be associated with adverse
effects on disease outcome, such as mortality and longer duration of mechanical
ventilation. In adults this has also been tested in a randomized controlled
trial with patients receiving either restrictive fluid treatment or a more
liberal approach. Restrictive fluid administration led to improved disease
outcome; shorter duration of mechanical ventilation and better oxygenation. As
there are pronounced differences in fluid homeostasis and nutrient requirements
between children and adults, these findings cannot be readily compared to the
pediatric population. Research into this subject in the pediatric population is
therefore essential to determine optimal fluid treatment.
Study objective
This research project aims to determine the feasibility of setting up a
randomized controlled trial to study the effects of different fluid management
protocols on the outcome of mechanically ventilated pediatric patients with
acute infectious lung disease. Specifically, this implies lowering the standard
fluid intake in these children in order to avoid fluid overload and evaluating
whether this is a feasible and achievable goal.
Study design
An investigator-initiated single-center prospective feasibility and pilot study
in preparation of a (multi-center) randomized controlled trial. The study will
be conducted in the pediatric intensive care unit (PICU) of the Emma Children*s
Hospital, Academic Medical Center at the University of Amsterdam. Within 12
hours after starting mechanical ventilation, patients will be randomized to
either of the fluid treatment regimes and treated accordingly.
Intervention
Patients will receive a restrictive fluid regimen consisting of 70% of normal
fluid recommendations or a liberal fluid regimen consisting of >85% of normal
fluid recommendations. This fluid treatment regimens were chosen in such a way
that caloric requirements can still be met. In children below 1 year old, or
children from 0-10 kg of weight, the calorie intake is set slightly higher, as
these infants need relatively more energy per kg body weight.
Study burden and risks
The possible risks in this study are hypotension (and/or cardiovascular
instability) or electrolyte imbalances. It is our perception however, that
these risks (of the intervention) are comparable to the current standard
clinical practice (control group) and that the interventional treatment will
rather benefit than harm the subjects. Therefore, we believe that the benefits
of this study are greater when compared to the potential risks.
We specifically chose this patient group for this study as this group of
patients is notoriously known to develop fluid overload. We chose to include
only patients with acute infectious respiratory disease and exclude patients
with cardiac comorbidities as these patients often develop fluid overload due
to cardiogenic failure. This selection of patients creates a more homogeneous
and reproducible patient cohort with similar illnesses and causes of fluid
overload.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Signed informed consent by the parents or legal caretakers
- Admitted to the pediatric intensive care unit (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 the investigator or pediatrician on duty).
- Patients with 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 for shock on admission
- Acute kidney injury with need for renal replacement therapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL55053.018.16 |