The Efficient PICU Fluid Care Evaluation

N/ANot Yet RecruitingNCT06644508

Radboud University Medical Center90 enrolled

Overview

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

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.

Interventions

Strict adherence to European guidelinesOTHER

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.

Eligibility

Sex: ALLMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative fluid balance on day 3 in ml/kg

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).

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

Secondary Outcomes

Daily cumulative fluid balance on in ml/kg

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).

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

Protein intake in gr/kg/day

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

Time frame: For ten days after start of mechanical ventilation

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

Daily cumulative diuretics dose in mg/kg

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

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

Blood urea nitrogen (BUN) in mmol/L

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

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

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

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

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

Daily potassium levels in mmol/L every 24 hours

During mechanical ventilation 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

Daily sodium levels in mmol/L every 24 hours

During mechanical ventilation 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

Daily lactate measurement in mmol/L every 24 hours

During mechanical ventilation 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

Daily pH measurement every 24 hours

During mechanical ventilation daily pH measurement every 24 hours

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

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

During mechanical ventilation 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

Daily vasoactive-inotropic score every 24 hours

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

Time frame: From start of mechanical ventilation for ten days

Daily highest 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

Time frame: From start of mechanical ventilation for ten days

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

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

Time frame: From start of mechanical ventilation for ten days

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

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

Time frame: From start of mechanical ventilation for ten days

Duration of IMV in days

Duration of invasive mechanical ventilation is noted in days

Time frame: From start of mechanical ventilation for ten days

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

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

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

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

Time frame: From start of mechanical ventilation for ten days

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

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

Time frame: From start of mechanical ventilation for ten days

Lenght of pediatric intensive care (PICU) stay in days

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

Newly acquired pulmonary infections (yes/no)

Time frame: From start of mechanical ventilation for ten days

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

Time frame: From start of mechnical ventilation for ten dys

Daily fluid intake in ml/kg every 24 hours

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

Time frame: From start of mechanical ventilation for ten days

Caloric intake in kcal/kg every 24 hours

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

Time frame: From start of mechanical ventilation for ten days

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

Time frame: From start of mechnical ventilation for ten days

The Efficient PICU Fluid Care Evaluation

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts