Critical Illness Clinical Trial
— LESSEROfficial 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.
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | November 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 10 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | In- and exclusion rate | Through study completion, an average of 1 week | No | |
Other | Adherence to treatment arms | Through study completion, an average of 1 week | No | |
Other | Need for fluid bolus | Through study completion, an average of 1 week | Yes | |
Other | Need for diuretics | Through study completion, an average of 1 week | Yes | |
Other | Need for vasopressors or inotropic drugs | Through study completion, an average of 1 week | Yes | |
Other | Energy and protein intake | Through study completion, an average of 1 week | Yes | |
Other | Gastrointestinal complaints | Through study completion, an average of 1 week | Yes | |
Other | Hemodynamic indices | Through study completion, an average of 1 week | Yes | |
Other | Occurrence of electrolyte imbalances | Through study completion, an average of 1 week | Yes | |
Primary | Cumulative fluid balance | First week of mechanical ventilation | No | |
Primary | Body weight | First week of mechanical ventilation | No | |
Secondary | Duration of mechanical ventilation | Through study completion, an average of 1 week | No | |
Secondary | Oxygenation indices | Through study completion, an average of 1 week | No | |
Secondary | Mortality | Up to 90 days after admission | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Completed |
NCT03671447 -
Enhanced Recovery After Intensive Care (ERIC)
|
N/A | |
Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
Completed |
NCT04239209 -
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
|
N/A | |
Completed |
NCT05531305 -
Longitudinal Changes in Muscle Mass After Intensive Care
|
N/A | |
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Completed |
NCT02916004 -
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
|
N/A | |
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04479254 -
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
|
N/A | |
Recruiting |
NCT04475666 -
Replacing Protein Via Enteral Nutrition in Critically Ill Patients
|
N/A | |
Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
Completed |
NCT02899208 -
Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
|
N/A | |
Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
Recruiting |
NCT02163109 -
Oxygen Consumption in Critical Illness
|
||
Completed |
NCT02358577 -
Early In-bed Cycling in Critically Ill Children
|
Phase 1/Phase 2 |