Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644508
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
The Efficient PICU Fluid Care Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficient PICU Fluid Care Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LESSER-2
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 eg 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 ie 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
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 eg 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 ie 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 mlkgday for neonates and 100 mlkgday 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 15 gkgday
Diuretics The choice and route of diuretics will be at the treating physicians 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
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 mlkgday for neonates and 100 mlkgday 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 15 gkgday
Diuretics The choice and route of diuretics will be at the treating physicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None