Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000107820
Ethics application status
Approved
Date submitted
19/12/2011
Date registered
23/01/2012
Date last updated
23/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Sterofundin versus Ringer's Lactate on Acid-base balance and electrolyte status in paediatric patients undergoing major urogenital surgery.
Scientific title
Sterofundin versus ringer's lactate on improvement of acid-base and electrolytes status in paediatric patients
Secondary ID [1] 273451 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1. to determine any significant differences in acid base balance in paediatric patients undergoing major surgery . 279245 0
2. to determine any significant differences in electrolyte balance and haemodynamic stability in paediatric patients undergoing major surgery. 279246 0
Condition category
Condition code
Anaesthesiology 279450 279450 0 0
Other anaesthesiology
Anaesthesiology 285612 285612 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of sterofundin as main intraoperative fluid in patients.
Sterofundin is used for maintenance of intra-operative fluid (amount according to 4:2:1 rule ie 4mls/kg for 1st 10kg, then 2mls/kg for next 10 kg and 1ml/kg for the remaining weight of the patient). It is also used for replacement of less than 10% plasma volume losses where replacement is given via intra venous route.
Intervention code [1] 283777 0
Treatment: Drugs
Comparator / control treatment
administration of ringer's lactate as main intraoperative fluid in patients.
Ringer’s lactate is a balanced solution containing sodium (130mmol/l), potassium (5mmol/l), calcium and magnesium (both at 1mmol/l), chloride (112mmol/l) and lactate (27mmol/l) therefore it is actually slightly hypotonic. Its osmolarity is 276mOsm/l which renders it slightly hypo-osmolar to plasma.
Ringer's Lactate is used for maintenance of intra-operative fluid (amount according to 4:2:1 rule ie 4mls/kg for 1st 10kg, then 2mls/kg for next 10 kg and 1ml/kg for the remaining weight of the patient). It is also used for replacement of less than 10% plasma volume losses where replacement is given via intra venous route.
Control group
Active

Outcomes
Primary outcome [1] 286012 0
pH via arterial blood gases measurements.
Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas is taken one hour postoperatively.
From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded. This will assess whether the ph is decreased or increased from patient's baseline.
Timepoint [1] 286012 0
A sample size calculation based on the expected 0.05 difference in pH in the mean population, and alpha of 0.05 and beta of 80%, leads to a minimum sample size of 15 in each side.
Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas are taken one hour postoperatively.
From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded.
Secondary outcome [1] 294973 0
chloride.
Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas is taken one hour postoperatively.
From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded.
Timepoint [1] 294973 0
A sample size calculation based on the expected 5 mmol difference in chloride in the mean population, and alpha of 0.05 and beta of 80%, leads to a minimum sample size of 25 in each side

Eligibility
Key inclusion criteria
The inclusion criteria for this study required the patients to be of paediatric age group (more than 1 year old to less than 13 years old), to be of ASA physical status I, II or III, undergoing major elective Urogenital surgery (duration of more than 2 hours)
Minimum age
1 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with renal failure or renal impairment, cardiac or liver failure, anomalies of the heart, hypervolaemic states, severe generalised oedema, electrolyte imbalance, metabolic acidosis and known allergies to sterofundin .

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3976 0
Malaysia
State/province [1] 3976 0

Funding & Sponsors
Funding source category [1] 284411 0
University
Name [1] 284411 0
university malaya
Country [1] 284411 0
Malaysia
Primary sponsor type
University
Name
university malaya
Address
faculty of medicine,
Lembah pantai,
50603 kuala lumpur.
Country
Malaysia
Secondary sponsor category [1] 283340 0
None
Name [1] 283340 0
Address [1] 283340 0
Country [1] 283340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286365 0
university malaya medical centre ethics comittee
Ethics committee address [1] 286365 0
lembah pantai,
50603 kuala lumpur
Ethics committee country [1] 286365 0
Malaysia
Date submitted for ethics approval [1] 286365 0
Approval date [1] 286365 0
Ethics approval number [1] 286365 0

Summary
Brief summary
Perioperative fluid comprises of basic maintenance requirement, replacement of fluid losses and fasting deficits. The aims of perioperative fluid therapy are to maintain correct fluid and electrolyte balance and adequate vascular volume which will ensure cardiovascular stability, organ perfusion and adequate tissue oxygenation .
Most of the fluids given perioperatively are used for replacing deficits and third space losses which consist mainly of extra cellular fluid . Therefore the hydrating solution should ideally have a composition of electrolytes as similar to plasma as possible. This favours crystalloids which are high in sodium and chloride concentration and have low concentrations of potassium, bicarbonate and calcium. Examples of crystalloids that approximate these ideals are ringer’s lactate and sterofundin. The two fluids used in this study, sterofundin and ringer’s lactate are balanced crystalloids. The composition of which is very similar to plasma composition. Sterofundin or ringerfundin is a balanced isotonic solution for intravenous infusion with electrolyte composition very similar to plasma (Na 140, k 4.0, Ca 2.5, Mg 1, Cl 127mmol/l. It also has a potential base excess of zero and contains acetate (24mmol/l) and malate(5mmol/l) which is widely metabolized in all organs and muscles, resulting in low oxygen consumption (1.4l oxygen per litre solution).
Ringer’s lactate is a balanced solution containing sodium (130mmol/l), potassium (5mmol/l), calcium and magnesium (both at 1mmol/l), chloride (112mmol/l) and lactate (27mmol/l) therefore it is actually slightly hypotonic. Its osmolarity is 276mOsm/l which renders it slightly hypo-osmolar to plasma. Its potential base excess is 3 mmol/l and oxygen consumption is higher than that of sterofundin at 1.8l oxygen per litre solution. This minor difference in oxygen consumption would be actually significant in a perioperative paediatric patient who has to cope with other stresses of surgery and anaesthesia. The lactate in ringer’s lactate was added in order to reduce the chloride load and act as a bicarbonate precursor, therefore reducing likelihood of hyperchloraemic acidosis seen after large infusions of normal saline. However, the metabolism of lactate is dependent on the kidney and liver, and as such, when the functions of these organs are compromised, there will be lactate accumulation as well as reduction in production of bicarbonate resulting in lactic acidosis.Sterofundin has been compared with ringer’s lactate use for resuscitation in septic oncologic adult patients where it has been found to be associated with a better preservation of electrolyte and acid-base pattern . However, few data exist on perioperative use of sterofundin in children. This study aims to elicit any significant changes in sodium, chloride, pH and base excess levels when sterofundin is used in paediatric patients undergoing major surgery as compared to ringer’s lactate usage. Ideally, there should be minimal changes in these parameters as compared to the baseline levels as there are many undesirable and dangerous effects associated with moderate to severe derangement of acid base and electrolytes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33432 0
Address 33432 0
Country 33432 0
Phone 33432 0
Fax 33432 0
Email 33432 0
Contact person for public queries
Name 16679 0
Ina Ismiarti Shariffuddin
Address 16679 0
department of anaesthesia,
Faculty of medicine,
University malaya,
Jalan lembah pantai,
50603 kuala lumpur
Country 16679 0
Malaysia
Phone 16679 0
60122353134
Fax 16679 0
60379556705
Email 16679 0
[email protected]
Contact person for scientific queries
Name 7607 0
Ina Ismiarti Shariffuddin
Address 7607 0
department of anaesthesia,
Faculty of medicine,
University malaya,
Jalan lembah pantai,
50603 kuala lumpur
Country 7607 0
Malaysia
Phone 7607 0
60122353134
Fax 7607 0
60379556705
Email 7607 0
[email protected]

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