Please select the eligibility criteria that correspond to the clinical trial below.
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.


Options:
A: Inclusion Criteria:

* All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study

Exclusion Criteria:

* Children with illness that have primary fluid and electrolyte imbalance such as:

  * Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (\<35oC), tachycardia, prolonged capillary filling time (\>3 seconds), hypotension (BP \< 5th percentile for age), oliguria (\<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
  * Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes \& dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
  * Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
* Abnormal serum sodium or Hyperglycemia at Presentation:

  * Hyponatremia : serum sodium \< 130 mmol/L.
  * Hypernatremia : serum sodium \>150 mmol/L.
  * Hyperglycemia: blood glucose \> 180 mg/ dl.
* Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
* Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.
B: Inclusion Criteria:

* Age 1 month to 18 years
* ICU stay \>24 hours
* Normal seric sodium (135 - 145 mEq/L).
* Requirement of IV maintenance solutions \>80% total fluids intake

Exclusion Criteria:

* Patients with diagnoses of renal failure (serum creatinine \>1 g/dl in \<3 years old children, \>1,5 in \>3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
* Diuretics use in the first 48 hours thereafter indicated IV solutions.
* Plasma glucose is \>200 mg%.
* Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
C: Inclusion Criteria:

* 1 month to 18 years of age
* Require IV fluids for at least 8 hr.
* Baseline serum sodium \>=136 mmol/L \& \<=145 mmol/L

Exclusion Criteria:

* Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
* Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
* Acute neurological illness such as meningitis or encephalitis
* Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)
D: 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.

Answer: D