None listed
Conditions
Brief summary
Hypothesis: Balanced fluids (Plasma-Lyte and Compound Sodium Lactate) will lower the prevalence of high chloride rise (greater than or equal to 5mmol/L) compared to 0.9 % sodium chloride solution. Study purpose: To demonstrate if balanced solutions are better than 0.9% sodium chloride as fluid therapy in critically ill children in PICU. Study design: Single centre, open label, randomised controlled trial. Intervention: Random assignment of individual patients (less than 16 yrs) into three groups – 0.9% Sodium Chloride solution, Plasma-Lyte 148 (PL) and Compound Sodium Lactate solution (CSL). Outcomes Primary Outcome • Increase in serum chloride level greater than or equal to 5mmol/L from baseline value to the highest chloride level within 48 hours from the time of randomisation Key Secondary Outcomes • Survival free of Acute Kidney Injury (AKI) • Survival free of organ dysfunction • Survival free of new onset AKI • Duration of ICU / Hospital stay
Interventions
Arm 1 - Plasma-Lyte - 148
Arm 2 - Compound Sodium Lactate solution
Parent information leaflet with consent forms will be provided. The staff will be informed about the two intervention fluid arms.
The intervention will be provided individually after consent.
The research coordinator will screen and consent patients/parents. Once recruited, the junior doctor will be adviced to prescribed the appropriate intravenous fluid therapy as per randomisation. The bedside nurse will administer the inter
Arm 1 - Plasma-Lyte - 148 Arm 2 - Compound Sodium Lactate solution Parent information leaflet with consent forms will be provided. The staff will be informed about the two intervention fluid arms. The intervention will be provided individually after consent. The research coordinator will screen and consent patients/parents. Once recruited, the junior doctor will be adviced to prescribed the appropriate intravenous fluid therapy as per randomisation. The bedside nurse will administer the intervention fluid therapy as directed by the clinician. The amount, rate and duration of maintenance fluid and bolus therapy will be dictated by the attending clinician as per institutional protocol. The institutional protocol aligns with international practice on administering intravenous maintenance fluid therapy. Therefore, maintenance fluid requirements are calculated at 4ml/kg/hr for the first 10 kgs, 2ml/kg/hr for next 10 and 1 ml/kg/hr there after according to the weight of the child. As our primary outcome is a biochemical end-point, we will need blood gases on admission, during PICU stay and at discharge. These will amount to 4 samples if the patient was in PICU for 2 days (usually length of stay for most PICU patients). Blood gases will be preferentially taken from an already in-situ arterial or venous line and be collected along with routine morning bloods where appropriate. If there are no invasive lines present and the peripheral venous cannula does not bleed back, a capillary blood gas sample will be taken. This is expected to be needed in a minority of patients. The children will be part of the trial until discharge from Paediatric Intensive Care Unit (PICU) or cessation of intravenous fluid therapy (whichever is earlier). The intervention will only occur on the PICU and be administered until discharge from PICU. The expected duration of intervention is estimated to be around 3-5 days ( around the median PICU length of stay). All interventions will be assessed retrospectively by automated data collection on a monthly basis to ensure adherence to prescription and study protocol.
Sponsors
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 16 Years
Healthy volunteers
No
Inclusion criteria
1. All patients – birth to an age of less than 16 years - admitted to the Paediatric Intensive Care Unit (and) 2. Attending clinician decides that intravenous fluid therapy is required 3. Admission Na >130mmol/L 4. New admissions to ICU within the last 24 hours
Exclusion criteria
1. Age greater than or equal to 16 years. 2. Patients admitted with a cardiac condition. 3. Received intravenous fluid therapy for >4 hours in PICU. 4. Patients admitted to the ICU with disease-specific protocols that necessitate specific fluid requirements such as: the treatment of burns; following liver transplantation surgery; post renal transplant surgery; diabetic ketoacidosis. 6. Patients with traumatic brain injury or those considered at risk of developing cerebral edema 7. Patients with pre-existing kidney disease (chronic kidney disease as defined by KDIGO criteria or under the ongoing care of a nephrologist) 8. Oncology patients who need hyperhydration.
Outcome results
None listed