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NCT Number: NCT06644508

The Efficient PICU Fluid Care Evaluation

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

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Key information

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation Edema Fluid Balance Fluid Overload Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

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About this study

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:
  • Current practice group.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strict adherence to European guidelines

Other

The goal is to maintain a neutral fluid balance throughout the course of intubation if clinical practice allows. Therefore:

  • From the start of mechanical ventilation, the maximum maintenance fluids is 65% of the maintenance fluids proposed by the Holliday & Segar formula. Fluid resuscitation in the first hours after intubation is at the discretion of the attending physician.
  • Any other interventions to maintain a neutral fluid balance (e.g., starting diuretics, reducing fluid boluses, decreasing creep fluids, or using more concentrated enteral feeding) are at the discretion of the attending physician.
  • Throughout the intervention, the attending physician decides if clinical practice allows for a decrease in fluid balance, and international feeding goals must always be met.

Primary outcomes

  1. Cumulative fluid balance on day 3 in ml/kg

    Time frame: From start mechanical ventilation to 72 hours after start of mechanical ventilation

    Cumulative fluid balance (CFB) over the course of three days after the start of mechanical ventilation is noted in ml/kg. CFB is calculated as a sum of daily (fluid intake [liters] - total output [liters])/ body weight (kilograms).

Secondary outcomes

  1. Daily cumulative fluid balance on in ml/kg

    Time frame: For 10 days, CFB is noted every day at 00:00

    Daily cumulative fluid balance (CFB) over the course of mechanical ventilation is noted in ml/kg. CFB is calculated as a sum of daily (fluid intake [liters] - total output [liters])/ body weight (kilograms).

  2. Protein intake in gr/kg/day

    Time frame: For ten days after start of mechanical ventilation

    Protein intake in gr/kg/day will be daily noted

  3. Bodyweight in grams

    Time frame: Bodyweight in grams will be measured at start of mechanical ventilation and at 72 hours after start of mechanical ventilation

    Bodyweight in grams

  4. Daily cumulative diuretics dose in mg/kg

    Time frame: From start of mechnical ventilation for ten days, cumulative diuretic dose will be noted at 00:00

    Cumulative diuretics dose will be daily noted in mg/kg.

  5. Blood urea nitrogen (BUN) in mmol/L

    Time frame: BUN will be measured at 24 hours, 72 hours and at 120 hours after start of mechanical ventilation

    During the course of mechanical ventilation blood urea nitrogen (BUN) is measured in mmol/L

  6. Daily creatinine level in µmol/L

    Time frame: Creatinine levels will be noted at: 24, 72 hours and 120 after start of mechanical ventilation

    Daily creatinine level in µmol/L

  7. Daily KDIGO stages (1,2 or 3) will be noted every 24 hours

    Time frame: From start of mechanical ventilation to 120 hours after start of mechanical ventilation.

    Daily KDIGO stages will be noted every 24 hours depending on their urine production. KDIGO 1= &lt;0.5ml/kg/h for 6-12 hours, KDIGO 2 = &lt;0.5ml/kg/h for &gt;12 hours, KDIGO 3 = &lt;0.3ml/kg/h for 24 hours or anuria for &gt;12 hours

  8. Daily potassium levels in mmol/L every 24 hours

    Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning

    During mechanical ventilation daily potassium levels in mmol/L every 24 hours

  9. Daily sodium levels in mmol/L every 24 hours

    Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning

    During mechanical ventilation daily sodium levels in mmol/L every 24 hours

  10. Daily lactate measurement in mmol/L every 24 hours

    Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning

    During mechanical ventilation daily lactate measurement in mmol/L every 24 hours

  11. Daily pH measurement every 24 hours

    Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning

    During mechanical ventilation daily pH measurement every 24 hours

  12. Daily ketone levels in blood every 24 hours in mmol/L

    Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning

    During mechanical ventilation daily ketone levels in blood every 24 hours in mmol/L

  13. Daily vasoactive-inotropic score every 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Vasoactive-inotropic score is calculated by: [dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)]

  14. Daily highest heart rate in beats per minute from every previous 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily highest heart rate in beats per minute from every previous 24 hours

  15. Daily lowest heart rate in beats per minute from every previous 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily lowest heart rate in beats per minute from every previous 24 hours

  16. Daily mean mean arterial pressure (so mean MAP) over every previous 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily mean mean arterial pressure (so mean MAP) over every previous 24 hours. Mean MAP is calculated by calculating the mean from blood pressure from hourly collected data

  17. Daily mean heart rate in beats per minute over every previous 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily mean heart rate in beats per minute over every previous 24 hours. Mean Mean heart rate is calculated by calculating the mean heartrate from hourly collected data

  18. Duration of IMV in days

    Time frame: From start of mechanical ventilation for ten days

    Duration of invasive mechanical ventilation is noted in days

  19. Duration of high flow nasal canula therapy after end of mechanical ventilation in hours

    Time frame: From the end of mechanical ventilation up to ten days after start of mechanical ventilation

    Duration of high flow nasal canula therapy after end of mechanical ventilation in hours

  20. Need for extracorporeal organ support (ECMO) is noted (yes/no)

    Time frame: From start of mechanical ventilation to day ten after start of emchanical ventilation

    Need for extracorporeal organ support (ECMO) is noted (yes/no)

  21. Daily mean oxygenation saturation index is noted every 24 hours only when SpO2 was below 97%

    Time frame: From start of mechanical ventilation for ten days

    During IMV daily mean oxygenation saturation index is noted every 24 hours only when SpO2 was below 97%. This is calculated by: ([Paw x FiO2]/SpO2) × 100

  22. Mean daily P/F ration is noted from every previous 24 hours

    Time frame: From start of mechanical ventilation for ten days

    During IMV mean daily P/F ration is noted from every previous 24 hours

  23. Lenght of pediatric intensive care (PICU) stay in days

    Time frame: From start of mechanical ventilation to 10 days after start mechanical ventilation

    Lenght of pediatric intensive care (PICU) stay in days

  24. Newly acquired pulmonary infections (yes/no)

    Time frame: From start of mechanical ventilation for ten days

    Newly acquired pulmonary infections (yes/no)

  25. Total daily fluid balance is noted in ml/kg every 24 hours

    Time frame: From start of mechnical ventilation for ten dys

    Total daily fluid balance is noted in ml/kg every 24 hours

  26. Daily fluid intake in ml/kg every 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily fluid intake will be noted in ml/kg ervery 24 hours

  27. Caloric intake in kcal/kg every 24 hours

    Time frame: From start of mechanical ventilation for ten days

    Daily caloric intake in kcal/kg will be noted every 24 hours

  28. Daily urine production in ml//kg from every 24 hours

    Time frame: From start of mechnical ventilation for ten days

    Daily urine production in ml//kg from every 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Joris Lemson, MD PhD

CONTACT

[email protected]

0031243617273

Michiel Schwerzel, MSc

CONTACT

[email protected]

0031243617273

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: LESSER-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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