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Trial registered on ANZCTR


Registration number
ACTRN12619001228178
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
5/09/2019
Date last updated
19/01/2023
Date data sharing statement initially provided
5/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Buffered bicarbonate solutions for abdominal surgery
Scientific title
The physiochemical effects of a bicarbonate buffered solution versus Hartmann's solution during major abdominal surgery: a randomized, open-label, non-inferiorty study
Secondary ID [1] 299040 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major abdominal surgery 314056 0
Condition category
Condition code
Metabolic and Endocrine 312444 312444 0 0
Other metabolic disorders
Surgery 312512 312512 0 0
Other surgery
Oral and Gastrointestinal 312513 312513 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible and enrolled patient who are scheduled for major abdominal surgery will be randomised to receive intravenous buffered bicarbonate solution for all crystalloid fluid infusions during surgery only with perioperative fluid charts reviewed to determine administered fluid therapy volumes. The dose administered will be clinician dependent.
Intervention code [1] 315314 0
Treatment: Drugs
Comparator / control treatment
Eligible and enrolled patient who are scheduled for major abdominal surgery will be randomised to receive intravenous Hartmann's solution for all crystalloid fluid infusions during surgery only with perioperative fluid charts reviewed to determine administered fluid therapy volumes. The dose administered will be clinician dependent.
Control group
Active

Outcomes
Primary outcome [1] 321092 0
Serum measurement of metabolic acidosis, reflected by standard base excess.
Timepoint [1] 321092 0
Arterial blood gas measurement immediately after surgery
Secondary outcome [1] 373968 0
Serum measurement of arterial blood electrolytes (sodium, potassium, calcium and chloride)
Timepoint [1] 373968 0
Immediately after surgery
Secondary outcome [2] 373969 0
Plasma lactate level
Timepoint [2] 373969 0
Immediately after surgery
Secondary outcome [3] 373970 0
Plasma creatinine
Timepoint [3] 373970 0
Daily evaluation of routine serum creatinine measurements from the immediate end of surgery until the date of hospital discharge.
Secondary outcome [4] 373971 0
Markers of endothelial function,glycocalax, as measured by plasma sydecan and heparan sulfate levels
Timepoint [4] 373971 0
Immediately at the end of surgery
Secondary outcome [5] 374338 0
Markers of endothelial function,glycocalax, as measured by urine sydecan and heparan sulfate levels
Timepoint [5] 374338 0
immediately post surgery

Eligibility
Key inclusion criteria
Adult aged 18 years or greater
Undergoing major abdominal surgery with an expected surgical duration of a minimum of 2 hours and an expected hospital admission of a minimum of 3 days
At risk of postoperative complications who have at least one of the following:
age equal to or greater than 70 years
known or document history of coronary artery disease
known or documented history of heart failure
diabetes with the receipt of oral hypoglycaemia agent and or insulin
preoperative serum creatinine greater than 200 micromol per litre
mobide obesity defined as a body mass index of equal to or greater than 35 kg per meter squared
peroperative serum albumin less than 30 gram/litre
anaerobic threshold of less than 12 ml per kilogram per minute
or
two or more of the following
ASA criteria 3 or 4
chronic respiratory disease
obesity of a body mass index between 30 and 35 kg per meter squared
aortic or peripheral vascular disease
preoperative haemoglobin less than 100 grams per litre
preoperative creatinine value of between 150-199 micromol/litre
anaerobic threshold 12-14 ml per kilogram per minute
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Urgent or time-critical surgery
ASA physical status 5
Chronic renal failure requiring dialysis
Pulmonary or cardiac surgery
Liver resection
Minor or intermediate surgery

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)
Blinded allocation using sequential opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
Statistical analysis will be performed using commercial statistical software, with a p value of 0.05 to indicate statistical significance. Outcomes will be compared after log transformation where appropriate. Comparisons will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data.

When there are baseline imbalances, logistic regression analysis will also be performed to adjust for them. Analysis will be on an intention-to-treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/02/2021
Actual
26/02/2021
Date of last participant enrolment
Anticipated
Actual
7/12/2021
Date of last data collection
Anticipated
25/02/2022
Actual
30/11/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14568 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27585 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303575 0
Hospital
Name [1] 303575 0
Austin Hospital
Country [1] 303575 0
Australia
Primary sponsor type
Individual
Name
Professor Rinaldo Bellomo
Address
Director, Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 303657 0
Hospital
Name [1] 303657 0
Austin Health
Address [1] 303657 0
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 303657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304105 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 304105 0
Level 8, Harold Stokes Building
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 304105 0
Australia
Date submitted for ethics approval [1] 304105 0
26/04/2019
Approval date [1] 304105 0
09/08/2019
Ethics approval number [1] 304105 0

Summary
Brief summary
The purpose for fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart, kidney and liver complications, improvements in time to mobilize, and a shorter duration of hospital stay.

During abdominal surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during major abdominal surgery is Hartmann’s solution. This is standard fluid therapy for all patients undergoing liver major abdominal surgery at Austin Health.
Hartmann’s solution has certain limitations in that it contains certain electrolytes (an essential mineral for normal health) as part of its normal content. One of these electrolyte is called lactate. Lactate is however reliant on the liver for its metabolism, which is why this fluid is not used in patients undergoing major liver surgery, including liver transplantation. However, during major abdominal surgery, there can be an additional stress from the surgery on the liver, which can in turn, affect the normal functioning of the liver. If the liver does not function normally, then lactate cannot be completely metabolized (broken down). This can affect normal acid base balance or body homeostasis.

In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Hartmann’s solution during major abdominal surgery. The bicarbonate buffered solution contains no “lactate” and may have a more favourable effect on the “acid-base” balance
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95826 0
Prof Rinaldo Bellomo
Address 95826 0
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95826 0
Australia
Phone 95826 0
+61 3 9496 5992
Fax 95826 0
+61 3 9496 3932
Email 95826 0
[email protected]
Contact person for public queries
Name 95827 0
Glenn Eastwood
Address 95827 0
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95827 0
Australia
Phone 95827 0
+61 3 9496 4835
Fax 95827 0
+61 3 9496 3932
Email 95827 0
[email protected]
Contact person for scientific queries
Name 95828 0
Rinaldo Bellomo
Address 95828 0
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95828 0
Australia
Phone 95828 0
+61 3 9496 5992
Fax 95828 0
+61 3 9496 3932
Email 95828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data underlying published results only.
When will data be available (start and end dates)?
Six months following main results publication; not end date determined
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-base basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses, etc
How or where can data be obtained?
Principal Investigator of the project via email on the above address.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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