None listed
Conditions
Brief summary
Hospitalised children regularly receive fluid that is infused through their veins (intravenous fluid therapy). The fluid is given to patients for resuscitation, as a routine daily requirement and to make up intravenous medicines. However, it can be harmful. When children are sick, they may hold on to fluid due to abnormal secretion of certain hormones. Additionally, their kidneys may not be working properly. These changes may lead to a child who inappropriately collects water in parts of the body, such as the lung. Unfortunately, this can cause difficulty with breathing and necessitate more support. Therefore, it may be beneficial to give less fluid and support their recovery. In this trial, we will directly compare a strategy of ‘less fluid’ to current standard care in critically ill children. With over 11,0000 children being admitted to intensive care units across Australia-New Zealand annually, knowledge from this project could potentially benefit many children.
Interventions
1:1 random assignment of individual patients into two groups – restrictive versus standard fluid strategy.
Stratified by primary diagnosis (cardiac/non-cardiac) prior to enrolment.
Restrictive fluid bundle (REDUCE bundle): Elements of the bundle will include restrictive maintenance fluid strategy, limiting fluid boluses, reducing volumes of drug delivery and initiating diuretics or peritoneal dialysis earlier.
Duration of exposure from randomisation to until discharge from the paediatric inten
1:1 random assignment of individual patients into two groups – restrictive versus standard fluid strategy. Stratified by primary diagnosis (cardiac/non-cardiac) prior to enrolment. Restrictive fluid bundle (REDUCE bundle): Elements of the bundle will include restrictive maintenance fluid strategy, limiting fluid boluses, reducing volumes of drug delivery and initiating diuretics or peritoneal dialysis earlier. Duration of exposure from randomisation to until discharge from the paediatric intensive care unit. Both doctors and nurses will deliver the restrictive fluid bundle to patients according to the study guideline developed by the PI in consultation with the PICU pharmacist and dietician. The guideline for the restrictive fluid bundle is inline with current unit practice of caring for fluid restricted patients. Assessment of adherence to the bundle will be captured using data obtained from the PICU electronic clinical record system. Using a restrictive bundle will include reducing: 1. Maintenance fluids to 50% (standards care is 75% for non-cardiac patients, 50% for patients undergoing cardiopulmonary bypass) 2. Smaller fluid bolus 5ml/kg (standard care:10-20ml/kg) 3. Drug dilutions will be assessed daily to see if they can be safely reduced. Limiting 0.9% saline flushes and post medication flushes to 3mls (standard care up to 10ml) or if line requires fluid to keep vein open (TKVO) limiting to 0.5ml/hr (standard care 1ml/hr) 4. Strengthen TPN concentration if possible 4. If fluid removal is required, consider commencing diuretics within 24hours of randomisation (standard care commencement usually day 1 or 2) 5. Peritoneal dialysis. Consider commencing within 24 hours of randomisation if clinically indicated (Standard care: usually commenced on day 1 or 2 however clinician may start when they feel it is appropriate)
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Admitted to PICU (and) 2. Mechanically ventilated at the time of randomisation (and) 3. Expected to be ventilated (if randomised at admission) or already ventilated (for those randomised on day 1 or 2) for greater than or equal to 6 hours 4. Age greater than or equal to 0 days to less than 18 years (17 years and 364 days)
Exclusion criteria
1. Admitted to PICU for greater than or equal to 48 hours 2. Children re-admitted to PICU less than or equal to 6 months of index (first randomisation) admission 3. Children needing hyperhydration for the risk of tumor lysis syndrome 4. Diabetic ketoacidosis 5. Post organ transplant patients 6. Patients in whom end of life care or palliative care has been instituted
Outcome results
None listed