Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Condition: Hyponatremia; Hypernatremia
MeSH terms: Hyponatremia; Hypernatremia
Study type: Interventional
Phase: Phase 3

Summary: 
      Children who are undergoing surgery need intravenous fluids to prevent dehydration and
      maintain their electrolyte balance. The current standard of care in these children is to use
      a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been
      tested. There is ongoing concern from the medical community that this type of fluid increases
      the child's risk of developing low sodium levels, and hence may not be safe for all children.
      Low sodium can lead to significant complications such as seizures, coma and even death, risks
      of which are often underestimated and not anticipated by their caregivers. Experts in the
      field suggest that giving a solution with a similar sodium content to that of blood (isotonic
      fluid) reduces the risk of these problems in these children. This study will compare these
      two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e.
      neither the patient nor caregivers or investigators will be aware which type of fluid the
      patient is receiving), in children following surgery. The investigators goal is to see which
      type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a
      lower risk of complications as described above.

      This is the first time such a study is preformed in pediatrics. There are unnecessary number
      of complications and potential deaths from this disorder, and hence the safety of everyday
      fluid practice in children needs to be scientifically tested. The results of this study will
      enable the investigators to propose scientifically based guidelines on how to minimize risks
      associated with intravenous infusions in children.
    

Detailed description: 
      Research Question:

      In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in
      a lower risk of acute hospital acquired plasma sodium derangements, occurring at any time
      during the study intervention? Primary efficacy objective -To determine the impact of
      postoperative administration of isotonic compared to hypotonic PMS on the risk of hospital
      acquired PNa derangements in pediatric surgical patients, occurring at any time during the
      study intervention.

      Secondary efficacy objectives: a) To determine the impact of postoperative administration of
      isotonic compared to hypotonic PMS on clinical sequelae related to acute PNa changes, in
      pediatric surgical patients. b) the independent predictors of hospital acquired PNa
      derangements will be explored.

      Study Design:

      This is a double-blind randomized controlled trial. Participants, health care providers, data
      collectors, and judicial assessors of outcomes will be blinded to the study intervention.

      Setting: McMaster Children's Hospital.

      Trial Intervention:

      Enrolled patients will be randomized postoperatively to receive either one of the following
      parenteral maintenance solutions: 1) hypotonic PMS, or 2) isotonic PMS. For the purposes of
      this study the hypotonic PMS will be 0.45%NaCl, and the Isotonic PMS will be 0.9% NaCl.
      Enrolled patients will receive their allocated treatment (provided there are no safety issues
      or concerns) until they are fully orally fed and the PMS rate is no greater than a rate
      required to "keep vein open (KVO)", to a maximum duration of 48 hours. The physician can
      thereafter administer the maintenance solution of their choice. The following parameters will
      be monitored in each study participant during the treatment period: hourly urine output,
      strict intake and output, 12 hourly fluid balances and daily weights. Blood and urine samples
      will be obtained on study patients every 12 hours until they are fully orally fed and the IV
      rate is at KVO, for a maximum of 48 hours. Any additional investigations ordered by the
      caring physician during the treatment and follow up period will also be recorded. Patients
      will be followed for clinical outcomes for 48 hours after the study intervention is
      discontinued, or until the time of discharge.
    

Intervention name(s): 0.9% NaCl; 0.45%NaCl
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Fluid
Isotonic Parenteral Fluid; Intravenous Fluid
Hypotonic Parenteral Fluid
Other intervention name(s): Isotonic saline; Hypotonic saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Parenteral Fluids; Isotonic; Hypotonic; Pediatric; Fluid overload