Fluid Restriction Keeps Children Dry

Critical Illness Clinical Trial

— LESSER  

Official title:

Fluids in Mechanically Ventilated Children With Acute Infectious Lung Disease: How Dry Should They be?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989051
• Other study ID #: 2016_096
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 5, 2016
• Last updated: December 7, 2016
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: December 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Job BM van Woensel, Professor
• Phone: 0031-20-5665769
• Email: ic.kinderen[@]amc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Fluid Overload
• Pulmonary Valve Insufficiency
• Respiratory Infection
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

Other:
• Restrictive fluid regimen
In this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child).
• Liberal fluid regimen
This is considered current standard clinical treatment, wherein patients will receive a fluid regimen of >85% of normal fluid recommendations (for a healthy child).

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

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