Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children

Summary

In children fluids are supplemented during surgery to provide volume, to maintain blood glucose levels, electrolyte balance and to meet the ongoing fluid losses during surgery. Fluid replacement during surgery since decades has been based on the Holliday and Segar method.These authors proposed that water maintenance in children includes: 100 millilitre (ml)/100 kilocalorie (kcal) for the first 10 kg of body weight, 50mL/100 kcal for 11-20 kg and 20mL/100 kcal for every kilogram of body weight above 20 kg. The maintenance electrolyte requirements of 3 mEq/100 kcal for sodium and 2 mEq/100 kcal for potassium per day, were based upon the electrolyte composition of breast and cow's milk. Based on these recommendations hypotonic fluid (0.45% saline) was considered as the ideal fluid for maintenance in children undergoing surgery.

Since the past many years there have been many documented cases of hyponatremia after administration of hypotonic fluids with potential for serious neurological injury in this group of patients.The use of Holliday and Segar's formula to calculate the maintenance fluid regimen in postoperative children leads to an overestimation of the volume of fluid needed, as there is a low urine output in this period. The postoperative period is at risk for non-osmotic secretion of anti-diuretic hormone (ADH), which reduces the ability of kidney to excrete free water and carries risk for development of hyponatraemia.Authors in favour of hypotonic solutions feel that hyponatremia results from excessive volume of fluid and isotonic solutions have risk of hypernatremia, interstitial fluid overload, excessive sodium excretion, and hyperchloremic metabolic acidosis.

Based on the increased incidence of hyponatremia in children undergoing surgery, the paediatric anaesthesia societies \[Society of Paediatric Anesthesia (SPA), Paediatric Anaesthesia Society of Great Britain and European society of Paediatric Anesthesia (ESPA)\] put forward guidelines for the type and amount of fluid to be administered during surgery.Since then normal saline is the commonly used fluid during the perioperative period.However recent studies have shown that the use of normal saline is associated with development of hyperchloremic metabolic acidosis and poor outcome.

Ringer lactate (RL) is a commonly used intravenous fluid during surgery and has been found to have decreased possibility of producing hyponatremia although it is a slightly hypotonic solution.Plasmalyte is an isotonic fluid which has been shown to maintain electrolyte balance and prevent hyponatremia as well as hyperchloremic acidosis in adult population.However plasmalyte has been less frequently used in paediatric population.Therefore this study is planned with the aim of comparing intravenous fluids, ringer lactate and plasmalyte in the perioperative period regarding the incidence of hyponatremia produced by these solutions, their effect on electrolytes and blood gases in children undergoing elective surgery.

Conditions

• Hyponatremia

Interventions

BIOLOGICAL

Ringer Lactate

BIOLOGICAL

Plasmalyte

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Principal Investigators

• Neerja Bhardwaj, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2017-02-28

Completion

2017-02-28

Countries

• India

Study Locations