Respiratory Insufficiency Requiring Mechanical VentilationLESSER-2NCT06644508
The Efficient PICU Fluid Care Evaluation
A study testing Strict adherence to European guidelines in people with Respiratory Insufficiency Requiring Mechanical Ventilation and Fluid Overload, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Respiratory Insufficiency Requiring Mechanical Ventilation, Fluid Overload, Fluid Balance
- What is being tested?
- Strict adherence to European guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 10 years and weight < 35 kg
- Receiving invasive mechanical ventilation (IMV) due to respiratory failure
- Expected duration of IMV > 48 hours
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam MC
Amsterdam, North Holland, 1100 DD
Reinout Bem, MD PhD, +31 566 8000, r.a.bem@amsterdamumc.nl
Reinout Bem, MD PhD
Radboudumc
Nijmegen, Gelderland, 6525 GA
Michiel Schwerzel, MSc, +31 243617273, michiel.schwerzel@radboudumc.nl
Joris Lemson, MD PhD
ErasmusMC
Rotterdam, South Holland, 3015 CN
Hanneke Bakker, MD PhD, +31 10703 62 55, johanna.bakker@erasmusmc.nl
Hanneke Bakker, MD PhD
About this study
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:
- What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?
- What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?
Read more
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
Read the 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:
- 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.
- Being tested
- Strict adherence to European guidelines
- Keywords
- Respiratory Insufficiency, Mechanical ventilation, Fluids, Fluid Balance, Edema, Fluid Overload, Lenght of mechanical ventilation, Childeren, Maintenance fluids
- Medical subject headings
- Edema, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Strict adherence to European guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From start mechanical ventilation to 72 hours after start of mechanical ventilation
Secondary outcomes (28)
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).
Measured: 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
Measured: For ten days after start of mechanical ventilation
Bodyweight in grams
Bodyweight in grams
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)]
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From start of mechanical ventilation for ten days
Duration of IMV in days
Duration of invasive mechanical ventilation is noted in days
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: From start of mechanical ventilation to 10 days after start mechanical ventilation
Newly acquired pulmonary infections (yes/no)
Newly acquired pulmonary infections (yes/no)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From start of mechnical ventilation for ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory Insufficiency Requiring Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multicentre prospective study (clinical implementation evaluation) with a before-after design with continuous recruitment and single measurements
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joris Lemson, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644508
- Sponsor's protocol ID
- 2023-16717
- Other IDs
- 2023
- Acronym
- LESSER-2
- Status last verified
- Sep 2024
- First submitted
- 10 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Demograpghics data * Outcome data
Publications
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.
PubMed 35281243Valentine 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.
PubMed 22824936Ingelse 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.
PubMed 31921715Diaz 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.
PubMed 29945586Charaya 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.
PubMed 37851328Brossier 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.
PubMed 36289081
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficient PICU Fluid Care Evaluation
- ClinicalTrials.gov ID
- NCT06644508
- Acronym / sponsor ID
- LESSER-2 / 2023-16717
- Keywords
- Respiratory Insufficiency, Mechanical ventilation, Fluids, Fluid Balance, Edema, Fluid Overload, Lenght of mechanical ventilation, Childeren
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre prospective study (clinical implementation evaluation) with a before-after design with continuous recruitment and single measurements
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Strict adherence to European guidelinesIn this intervention attending physicians will be encouraged to strictly adhere the European (ESPNIC) guidelines regarding fluid management. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < 10 years and weight < 35 kg
- Receiving invasive mechanical ventilation (IMV) due to respiratory failure
- Expected duration of IMV > 48 hours
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strict adherence to European guidelinesThe 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. | Other | Strict adherence to european guidelines |
Primary outcome
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).
28 secondary outcomes
Daily cumulative fluid balance on in ml/kg
Time frame: For 10 days, CFB is noted every day at 00:00
Protein intake in gr/kg/day
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
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
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
Time frame: From start of mechanical ventilation to 120 hours after start of 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
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
Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning
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
Time frame: From start of mechanical ventilation for ten days, at 08:00 in the morning
Daily vasoactive-inotropic score every 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
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
Time frame: From start of mechanical ventilation for ten days
Daily mean heart rate in beats per minute over every previous 24 hours
Time frame: From start of mechanical ventilation for ten days
Duration of IMV 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%
Time frame: From start of mechanical ventilation for ten days
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
Time frame: From start of mechanical ventilation for ten days
Caloric intake in kcal/kg 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 35281243Arrahmani 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.
- Background: PubMed 22824936Valentine 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.
- Background: PubMed 31921715Ingelse 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.
- Background: PubMed 29945586Diaz 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.
- Background: PubMed 37851328Charaya 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.
- Background: PubMed 36289081Brossier 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.
- Individual participant dataSharing planned: Yes. * Demograpghics data * Outcome data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Lemson, MD PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strict adherence to European guidelines in people with Respiratory Insufficiency Requiring Mechanical Ventilation and Fluid Overload, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joris Lemson, MD PhD (0031243617273, joris.lemson@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance on day 3 in ml/kg (time frame: From start mechanical ventilation to 72 hours after start of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644508, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.