Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Aug 13, 2008

Keywords

ClinConnect 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 com...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients, 6 months corrected age -16 years, undergoing surgery.
• • Within 6 hours of the immediate post-operative period.
• • Post-operative stay anticipated to be more than 24 hours.
• • Primary route of fluid administration is anticipated to be intravenous, in the first 24 hours following surgery.
• • Informed consent of parent/guardian.
• • Consent to participate from surgeon.
• Exclusion Criteria:
• • Patients under 6 months of age
• • Patients equal to or over 17 years of age
• • Patients with hemodynamic instability , defined as a requirement for continuous vasoactive infusion (e.g. epinephrine, dopamine, norepinephrine, phenylephrine, milrinone, or Dobutamine) to maintain blood pressure at the end of surgery.
• • Patients admitted into the "short stay" post-operative unit
• • Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
• • Patients with known pre-existing risk of PNa derangements: DI or SIADH
• • Chronic diuretic use - defined as use of any oral or intravenous diuretics for ≥ 7 days.
• • Known, uncorrected PNa derangement (PNa \< 134 or \> 146 mmol/L), identified peri-operatively (i.e. within 12 hours of surgery or during surgery).
• • Prior enrolment in this study
• • Patients or their guardians objecting to give consent.