None listed
Conditions
Brief summary
The administration of intravenous (IV) fluid is an extremely common therapy in children requiring hospital care. Recent research strongly suggests we must increase the concentration of sodium in intravenous fluid routinely given to hospitalised children, in order to minimise the potentially dangerous complication of low serum sodium concentration. Hence, fluids currently considered appropriate to administer for ongoing IV fluid maintenance include 0.9% saline or Plasma-Lyte (Registered Trademark) 148. 0.9% saline and Plasma-Lyte 148 have both been routinely administered to children as IV ‘bolus’ resuscitation (10-20 mls/kg given over 5-30 minutes) fluid for decades. The choice of which fluid is administered is largely dependent on the institution and the prescribing habits of individual clinicians. For example, children in Victoria commonly receive Plasma-Lyte 148, while those in New South Wales commonly receive 0.9% Saline. Theoretical benefits have been attributed to Plasma-Lyte 148 over 0.9% saline, but current clinical data is insufficient to recommend one of these fluids over the other. Recent research has also supported that fluids containing 0.9% saline or Plasma-Lyte 148 should be routinely given for ongoing IV fluid maintenance in children, in addition to their current use for IV ‘bolus’ fluids. Once again there is insufficient clinical data to recommend one fluid over the other, despite IV fluid prescription being the second most common prescription to occur in children admitted to hospital (second to analgesia/anti-pyretics). Plasma-Lyte 148 is considerably more expensive than 0.9% saline. Thus there is an urgent need for an interventional trial comparing 0.9% saline to Plasma-Lyte 148 for both IV fluid bolus and maintenance therapy in children admitted to hospital. The results of such a study will widely inform national and international fluid prescribing guidelines for children. This study will assign two clusters of participants by alternating treatments over consecutive time periods. It is designed to provide high quality feasibility data for a future multi-centre cluster randomized cross-over study of the same design. Children attending Starship Children’s Hospital, who require IV fluids will be assigned to use either 0.9% saline or Plasma-Lyte 148 as the primary crystalloid fluid therapy in a blinded fashion, in alternating four week blocks. Blinded study fluid will be used for fluid therapy in situations where the two study fluids are regarded as equivalent by the treating clinician. Children require varying amounts of glucose within the fluid administered, thus both glucose and non-glucose containing versions of the study fluids will be available and clearly labelled. As per current practice, clinicians will be able to add extra glucose and/or potassium to intravenous fluid bags.
Interventions
This study is designed to provide high quality feasibility data for a future multi-centre cluster randomized cross-over study. Children attending Starship Children’s Hospital, who require IV fluids will be assigned to use either 0.9% saline or Plasma-Lyte 148 (Registered Trademark) as the primary crystalloid fluid therapy in a blinded fashion, in alternating four week blocks. Blinded study fluid will be used for fluid therapy in situations where the two study fluids are regarded as equivalent b
This study is designed to provide high quality feasibility data for a future multi-centre cluster randomized cross-over study. Children attending Starship Children’s Hospital, who require IV fluids will be assigned to use either 0.9% saline or Plasma-Lyte 148 (Registered Trademark) as the primary crystalloid fluid therapy in a blinded fashion, in alternating four week blocks. Blinded study fluid will be used for fluid therapy in situations where the two study fluids are regarded as equivalent by the treating clinician, and will be administered for all resuscitation and maintenance fluid for up to 28 days after enrollment. Both 0.9% saline and Plasma-Lyte 148 (Registered Trademark) will be available for open-label administration in the rare situations, where, in the opinion of the treating specialist, there is a clinical indication for one fluid or the other. As per standard practice in children, the blinded study fluids will be available with and without added glucose, and the glucose will be clearly labelled on the bags as per current labeling guidelines. The amount and rate of fluid administration, along with the concentration of glucose will be determined by the clinicians managing the patient according to clinical need and in line with Starship Hospital's recommended best practice guidelines. The daily amount of all intravenous fluids administered (both blinded study fluid, open label crystaloids and other fluids such as blood products), will be recorded in the case report form for all participants.
Sponsors
Starship Hospital Paediatric Intensive Care Research Department
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
Patients admitted to Starship Children’s Hospital who require isotonic crystalloid fluid therapy. This includes patients presenting via the emergency department, operating theatres, ICU or directly to any inpatient ward (including interhospital transfers). Due to admission criteria of Starship, this will predominantly be children less than 15 years of age, but will include some older children and adults with specific conditions such as congenital heart disease and inborn errors of metabolism.
Exclusion criteria
-The clinician managing the patient has a need to administer a particular isotonic crystalloid solution. -The child is under 44 weeks corrected gestational age.
Outcome results
None listed