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Buffered bicarbonate solutions for abdominal surgery

The physiochemical effects of a bicarbonate buffered solution versus Hartmann's solution during major abdominal surgery: a randomized, open-label, non-inferiorty study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001228178
Enrollment
50
Registered
2019-09-05
Start date
2021-02-26
Completion date
2021-12-07
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Sponsors

Professor Rinaldo Bellomo
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 11, 2026