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ClinicalTrials.gov ID

NCT06644508

Lead Sponsor

Radboud University Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

90Estimated

Last Update Posted

Oct 16, 2024Actual

Start Date

Oct 2024Estimated

Primary Completion Date

May 2025Estimated

Completion Date

May 2025Estimated

Official Title

The Efficient PICU Fluid Care Evaluation

Brief Summary

The goal of this clinical trial is to evaluate and prevent fluid overload in critically ill, mechanically ventilated children. The main questions it aims to answer are:

1. What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?
2. What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?

Researchers will compare the effects of strict adherence to the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) guidelines regarding fluid balance (i.e. restricting fluid intake and preventing a positive fluid balance) to current local practice.

From the start to the end of invasive mechanical ventilation participants will be treated according to local practice or with the strict aim to prevent a positive fluid balance. Aiming to prevent a positive fluid balance, if this is possible given the clinical context, is at descretion of the attending physician. Minimal caloric intake requirements must be met.

Participants are studied for ten days during invasive mechanical ventilation or until discharge from the intensive care

Detailed Description

Objectives

• Compare current practices with strict adherence to ESPNIC guidelines regarding fluid management in critically ill children.
• Assess the effectiveness of maintaining a neutral cumulative fluid balance by day 3 (CFB3).

Study Design

• Type: Multicenter prospective study with a before-after design, continuous recruitment, and single measurements.

• Groups:

  1. Current practice group.
  2. ESPNIC guideline adherence group (restrictive fluid management).

Treatment

• Current Practice Group: Standard PICU treatment per local protocols.
• ESPNIC Guideline Adherence Group: Strict restrictive fluid strategy beginning within 24 hours of intubation, focusing on preventing cumulative positive fluid balance. ESPNIC guidelines recommend restricting total fluid intake to 65-80% of the Holliday and Segar formula. The Holliday and Segar formula is tailored for children under 10 kg: 150 ml/kg/day for neonates and 100 ml/kg/day for one-year-olds. This study will aim for a 65% restriction based on these calculations.

Feeding Enteral nutrition starts within 24-48 hours unless contraindicated, with caloric intake reaching 100% of resting energy expenditure by day 7 and protein intake exceeding 1.5 g/kg/day.

Diuretics The choice and route of diuretics will be at the treating physician's discretion.

Duration of Intervention Start: Onset of mechanical ventilation. End: End of mechanical ventilation.

Study Procedures Children will have routine blood samples taken daily during invasive mechanical ventilation (IMV), which align with standard clinical diagnostics. Body weight will be measured at admission, on day 3, and before extubation. Data on fluid intake, feeding, medication, and urine output will be gathered prospectively in the electronic patient dossier (EPD).

Adverse Events All adverse events will be recorded, with serious adverse events (SAEs) reported to the sponsor promptly.

• Respiratory Insufficiency Requiring Mechanical Ventilation
• Fluid Overload
• Fluid Balance

• Strict adherence to European guidelines

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age < 10 years and weight < 35 kg
• Receiving invasive mechanical ventilation (IMV) due to respiratory failure
• Inclusion possible within 24 hours of start of IMV
• Expected duration of IMV > 48 hours

Exclusion Criteria:

• Preterm (<37weeks gestational age)
• Preexistent (clinical) diagnosis of kidney disease
• Congenital cardiac defect with hemodynamic consequences or reduced cardiac function
• (Ongoing) shock with need for fluid resuscitation and/or vasoactive drugs
• Cardiovascular (including diuretics) drug use on admission (home medication)
• Pre-existent (clinical) diagnosis of liver failure
• Right of left heart failure
• Pulmonary hypertension
• ECMO treatment
• Receiving total parenteral nutrition on admission which won't be stopped
• Failure to include within 12 hours after start of IMV
• Expected duration of IMV < 48 hours
• Parents or caretakers unable to understand/speak Dutch language
• Surgery < 48 hours

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Radboud University Medical CenterOTHER

r.a.bem@amsterdamumc.nl+31 566 8000

johanna.bakker@erasmusmc.nl+31 10703 62 55