Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-10-31
2025-05-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Observation of current local practices
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.
No interventions assigned to this group
Strict adherence to european guidelines
In this intervention attending physicians will be encouraged to strictly adhere the European (ESPNIC) guidelines regarding fluid management.
Strict 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.
Interventions
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Strict 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joris Lemson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Amsterdam MC
Amsterdam, North Holland, Netherlands
ErasmusMC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Joris Lemson, MD PhD
Role: backup
Reinout Bem, MD PhD
Role: backup
Hanneke Bakker, MD PhD
Role: backup
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2023-16717
Identifier Type: -
Identifier Source: org_study_id
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