Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 18, 2016
October 1, 2016
5 months
October 12, 2016
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To find out the incidence of hyponatremia and hypernatremia between ringer lactate group and plasmalyte group
6 months
Secondary Outcomes (3)
To find out changes in serum antidiuretic hormone level between Ringer lactate and plasmalyte group
6 months
To find out changes in urine electrolytes between Ringer lactate and plasmalyte group
6 months
To find out changes in urine osmolality between Ringer lactate and plasmalyte group
6 months
Study Arms (2)
Ringer Lactate
EXPERIMENTALfluid
Plasmalyte
EXPERIMENTALfluid
Interventions
Eligibility Criteria
You may qualify if:
- Age: 2 - 8 years
- American society of anesthesiologist (ASA) - 1
- Laparoscopic surgical procedure of 2 hours duration requiring IV fluid administration for at least 24 hours
You may not qualify if:
- Uncorrected plasma sodium level before surgery
- Diseases which cause abnormal ADH secretion
- Renal and cardiac disease
- Chronic lung disease
- Cranial/thoracic surgery
- Recent loop diuretics use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012, India
Related Publications (1)
McNab S, Duke T, South M, Babl FE, Lee KJ, Arnup SJ, Young S, Turner H, Davidson A. 140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial. Lancet. 2015 Mar 28;385(9974):1190-7. doi: 10.1016/S0140-6736(14)61459-8. Epub 2014 Dec 1.
PMID: 25472864RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neerja Bhardwaj, MD
Post Graduate Institute of Medical Education and Research, Chandigarh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Junior Resident,Dept. of Anaesthesia and Intensive Care ,pgimer
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 18, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
October 18, 2016
Record last verified: 2016-10