Fluid Balance, Fluid Overload, Respiratory Insufficiency Requiring Mechanical Ventilation
Conditions
Keywords
Respiratory Insufficiency, Mechanical ventilation, Fluids, Fluid Balance, Edema, Fluid Overload, Lenght of mechanical ventilation, Childeren, Maintenance fluids
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.
Interventions
OTHERStrict adherence to European guidelines
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.
Sponsors
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre prospective study (clinical implementation evaluation) with a before-after design with continuous recruitment and single measurements
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative fluid balance on day 3 in ml/kg | 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
| Measure | Time frame | Description |
|---|---|---|
| Daily cumulative fluid balance on in ml/kg | 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). |
| Protein intake in gr/kg/day | For ten days after start of mechanical ventilation | Protein intake in gr/kg/day will be daily noted |
| Daily cumulative diuretics dose in mg/kg | 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. |
| Blood urea nitrogen (BUN) in mmol/L | 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 |
| Daily creatinine level in µmol/L | Creatinine levels will be noted at: 24, 72 hours and 120 after start of mechanical ventilation | Daily creatinine level in µmol/L |
| Daily KDIGO stages (1,2 or 3) will be noted every 24 hours | 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= <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 |
| Daily potassium levels in mmol/L every 24 hours | 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 |
| Daily sodium levels in mmol/L every 24 hours | 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 |
| Daily lactate measurement in mmol/L every 24 hours | 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 |
| Daily pH measurement every 24 hours | From start of mechanical ventilation for ten days, at 08:00 in the morning | During mechanical ventilation daily pH measurement every 24 hours |
| Daily ketone levels in blood every 24 hours in mmol/L | 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 |
| Daily vasoactive-inotropic score every 24 hours | From start of mechanical ventilation for ten days | Vasoactive-inotropic score is calculated by: \[dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)\] |
| Daily highest heart rate in beats per minute from every previous 24 hours | From start of mechanical ventilation for ten days | Daily highest heart rate in beats per minute from every previous 24 hours |
| Bodyweight in grams | Bodyweight in grams will be measured at start of mechanical ventilation and at 72 hours after start of mechanical ventilation | Bodyweight in grams |
| Daily mean mean arterial pressure (so mean MAP) over every previous 24 hours | 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 |
| Daily mean heart rate in beats per minute over every previous 24 hours | 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 |
| Duration of IMV in days | From start of mechanical ventilation for ten days | Duration of invasive mechanical ventilation is noted in days |
| Duration of high flow nasal canula therapy after end of mechanical ventilation in hours | 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 |
| Need for extracorporeal organ support (ECMO) is noted (yes/no) | From start of mechanical ventilation to day ten after start of emchanical ventilation | Need for extracorporeal organ support (ECMO) is noted (yes/no) |
| Daily mean oxygenation saturation index is noted every 24 hours only when SpO2 was below 97% | 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 |
| Mean daily P/F ration is noted from every previous 24 hours | From start of mechanical ventilation for ten days | During IMV mean daily P/F ration is noted from every previous 24 hours |
| Lenght of pediatric intensive care (PICU) stay in days | From start of mechanical ventilation to 10 days after start mechanical ventilation | Lenght of pediatric intensive care (PICU) stay in days |
| Newly acquired pulmonary infections (yes/no) | From start of mechanical ventilation for ten days | Newly acquired pulmonary infections (yes/no) |
| Total daily fluid balance is noted in ml/kg every 24 hours | From start of mechnical ventilation for ten dys | Total daily fluid balance is noted in ml/kg every 24 hours |
| Daily fluid intake in ml/kg every 24 hours | From start of mechanical ventilation for ten days | Daily fluid intake will be noted in ml/kg ervery 24 hours |
| Caloric intake in kcal/kg every 24 hours | From start of mechanical ventilation for ten days | Daily caloric intake in kcal/kg will be noted every 24 hours |
| Daily urine production in ml//kg from every 24 hours | From start of mechnical ventilation for ten days | Daily urine production in ml//kg from every 24 hours |
| Daily lowest heart rate in beats per minute from every previous 24 hours | From start of mechanical ventilation for ten days | Daily lowest heart rate in beats per minute from every previous 24 hours |
Countries
Netherlands
Contacts
Primary ContactJoris Lemson, MD PhD
Backup ContactMichiel Schwerzel, MSc
Outcome results
None listed