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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:
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
Study Design
Type: Multicenter prospective study with a before-after design, continuous recruitment, and single measurements.
Groups:
Treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation of current local practices | No Intervention | Current local practices regarding fluid management will be observed. Population: Critically ill children receiving mechanical ventilation due to respiratory insufficiency. Patients will be treated according to local protocols at the discretion of the attending physicians. | |
| Strict adherence to european guidelines | Active Comparator | In this intervention attending physicians will be encouraged to strictly adhere the European (ESPNIC) guidelines regarding fluid management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From start mechanical ventilation to 72 hours after start of mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | For 10 days, CFB is noted every day at 00:00 |
| Protein intake in gr/kg/day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joris Lemson, MD PhD | Contact | 0031243617273 | joris.lemson@radboudumc.nl | |
| Michiel Schwerzel, MSc | Contact | 0031243617273 | michiel.schwerzel@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Joris Lemson, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35281243 | Background | Arrahmani I, Ingelse SA, van Woensel JBM, Bem RA, Lemson J. Current Practice of Fluid Maintenance and Replacement Therapy in Mechanically Ventilated Critically Ill Children: A European Survey. Front Pediatr. 2022 Feb 23;10:828637. doi: 10.3389/fped.2022.828637. eCollection 2022. | |
| 22824936 | Background | Valentine SL, Sapru A, Higgerson RA, Spinella PC, Flori HR, Graham DA, Brett M, Convery M, Christie LM, Karamessinis L, Randolph AG; Pediatric Acute Lung Injury and Sepsis Investigator's (PALISI) Network; Acute Respiratory Distress Syndrome Clinical Research Network (ARDSNet). Fluid balance in critically ill children with acute lung injury. Crit Care Med. 2012 Oct;40(10):2883-9. doi: 10.1097/CCM.0b013e31825bc54d. |
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From publication until 15 years after publication
Data will be made available upon reasonable request to the corresponding author
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| ID | Term |
|---|---|
| D004487 | Edema |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Multicentre prospective study (clinical implementation evaluation) with a before-after design with continuous recruitment and single measurements
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|
Protein intake in gr/kg/day will be daily noted |
| For ten days after start of mechanical ventilation |
| Bodyweight in grams | Bodyweight in grams | 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. | 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 | BUN will be measured at 24 hours, 72 hours and at 120 hours after start of mechanical ventilation |
| Daily creatinine level in µmol/L | Daily creatinine level in µmol/L | 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 | 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 | 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 | 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 | 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 | 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 | 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)] | From start of mechanical ventilation for ten days |
| Daily highest heart rate in beats per minute from every previous 24 hours | Daily highest 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 | Daily lowest heart rate in beats per minute from 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 | 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 | 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 | From start of mechanical ventilation for ten days |
| Duration of IMV in days | Duration of invasive mechanical ventilation is noted in days | From start of mechanical ventilation for ten days |
| Duration of high flow nasal canula therapy after end of mechanical ventilation in hours | 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 |
| Need for extracorporeal organ support (ECMO) is noted (yes/no) | Need for extracorporeal organ support (ECMO) is noted (yes/no) | 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 | 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 | From start of mechanical ventilation for ten days |
| Lenght of pediatric intensive care (PICU) stay in days | Lenght of pediatric intensive care (PICU) stay in days | From start of mechanical ventilation to 10 days after start mechanical ventilation |
| Newly acquired pulmonary infections (yes/no) | Newly acquired pulmonary infections (yes/no) | From start of mechanical ventilation for ten days |
| Total daily fluid balance is noted in ml/kg every 24 hours | Total daily fluid balance is noted in ml/kg every 24 hours | 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 | 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 | From start of mechanical ventilation for ten days |
| Daily urine production in ml//kg from every 24 hours | Daily urine production in ml//kg from every 24 hours | From start of mechnical ventilation for ten days |
| Amsterdam MC | Amsterdam | North Holland | 1100 DD | Netherlands |
|
| ErasmusMC | Rotterdam | South Holland | 3015 CN | Netherlands |
|
| 31921715 | Background | Ingelse SA, Geukers VG, Dijsselhof ME, Lemson J, Bem RA, van Woensel JB. Less Is More?-A Feasibility Study of Fluid Strategy in Critically Ill Children With Acute Respiratory Tract Infection. Front Pediatr. 2019 Dec 10;7:496. doi: 10.3389/fped.2019.00496. eCollection 2019. |
| 29945586 | Background | Diaz F, Nunez MJ, Pino P, Erranz B, Cruces P. Implementation of preemptive fluid strategy as a bundle to prevent fluid overload in children with acute respiratory distress syndrome and sepsis. BMC Pediatr. 2018 Jun 26;18(1):207. doi: 10.1186/s12887-018-1188-6. |
| 37851328 | Background | Charaya S, Angurana SK, Nallasamy K, Jayashree M. Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). Indian J Pediatr. 2025 Jan;92(1):7-14. doi: 10.1007/s12098-023-04867-4. Epub 2023 Oct 18. |
| 36289081 | Background | Brossier DW, Tume LN, Briant AR, Jotterand Chaparro C, Moullet C, Rooze S, Verbruggen SCAT, Marino LV, Alsohime F, Beldjilali S, Chiusolo F, Costa L, Didier C, Ilia S, Joram NL, Kneyber MCJ, Kuhlwein E, Lopez J, Lopez-Herce J, Mayberry HF, Mehmeti F, Mierzewska-Schmidt M, Minambres Rodriguez M, Morice C, Pappachan JV, Porcheret F, Reis Boto L, Schlapbach LJ, Tekguc H, Tziouvas K, Parienti JJ, Goyer I, Valla FV; Metabolism Endocrinology and Nutrition section of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC). ESPNIC clinical practice guidelines: intravenous maintenance fluid therapy in acute and critically ill children- a systematic review and meta-analysis. Intensive Care Med. 2022 Dec;48(12):1691-1708. doi: 10.1007/s00134-022-06882-z. Epub 2022 Oct 26. |