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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]

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 .

2. to determine any significant differences in electrolyte balance and haemodynamic stability in paediatric patients undergoing major surgery.

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Anaesthesiology

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

university malaya

Address [1]

faculty of medicine,
Lembah pantai
50603 kuala lumpur

Country [1]

Malaysia

Primary sponsor type

University

Name

university malaya

Address

faculty of medicine,
Lembah pantai,
50603 kuala lumpur.

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

university malaya medical centre ethics comittee

Ethics committee address [1]

lembah pantai,
50603 kuala lumpur

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ina Ismiarti Shariffuddin

Address

department of anaesthesia,
Faculty of medicine,
University malaya,
Jalan lembah pantai,
50603 kuala lumpur

Country

Malaysia

Phone

60122353134

Fax

60379556705

[email protected]

Contact person for scientific queries

Name

Ina Ismiarti Shariffuddin

Address

department of anaesthesia,
Faculty of medicine,
University malaya,
Jalan lembah pantai,
50603 kuala lumpur

Country

Malaysia

Phone

60122353134

Fax

60379556705

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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