Fluids in mechanically ventilated children with acute infectious lung disease: how dry should they be?

Fluids in mechanically ventilated children with acute infectious lung disease: how dry should they be? - Fluids in pediatric acute infectious lung disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44104

Enrollment

Registered

2016-05-26

Start date

2016-10-06

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower respiratory tract infection pneumonia

Interventions

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 treatmen

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The main study parameters are (cumulative) fluid balance and body weight during the first week of mechanical ventilation.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)