Clinical Trial: Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial
Brief 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 Summary:
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 thereaf
Sponsor: Hamilton Health Sciences Corporation
Current Primary Outcome:
- Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) [ Time Frame: During the treatment and follow-up period. ]
- Hyponatremia [ Time Frame: during the study intervention ]Plasma sodium less than 135 mmol/L
Original Primary Outcome: Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) [ Time Frame: During the treatment and follow-up period. ]
Current Secondary Outcome: Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes. [ Time Frame: During the treatment and follow-up period ]
Original Secondary Outcome: Same as current
Information By: McMaster University
Dates:
Date Received: August 12, 2008
Date Started: March 2008
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015
