Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06644508
NA

The Efficient PICU Fluid Care Evaluation

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

Any - 10 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-10

Completion Date

2025-05

Last Updated

2024-10-16

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (3)

Radboudumc

Nijmegen, Gelderland, Netherlands

Amsterdam MC

Amsterdam, North Holland, Netherlands

ErasmusMC

Rotterdam, South Holland, Netherlands