None listed
Conditions
Brief summary
Albumin and dexamethasone are often administered to patients undergoing major surgery. Despite these drugs being commonly used, it is not known how they impact on the stress response to surgery. Albumin is an intravenous fluid made up of a normal physiological protein (albumin) in a salt solution, that is routinely administered to patients having major surgery. It is TGA approved and readily available in Australia. Dexamethasone is a steroid medication, often used in many types of surgery to reduce the risk of nausea and vomiting. It also has anti-inflammatory and pain relieving effects. It is also TGA approved and readily available in Australia. This pilot study aims to determine if giving albumin and dexamethasone immediately prior to surgery can reduce the stress response from surgery. Stress, or the inflammatory response during surgery can result in damage to the microvasculature (the smallest blood vessels in the body). By protecting these small vessels with dexamethasone and albumin, we hope to reduce the effects caused by the systemic inflammatory response that accompanies major surgery. The study is a collaboration between 5 major hospitals that specialize in major abdominal surgery. These are Austin Health, Peter MacCallum Cancer Center, Warringal Private Hospital, Knox Private Hospital and Auckland City Hospital. Importantly, for all patients in the study, standard of care will be maintained during anaesthesia, surgery, and the entire perioperative process and there will be NO deviation at any stage from acceptable routine care. For this pilot study, patients undergoing 3 different types of major abdominal surgery will be randomized (allocated by chance) into two groups. The ‘Treatment Group’ will receive 16mg of dexamethasone and 100ml of 20% albumin solution 30-60minutes prior to the start of surgery, and a solution of 4% albumin to meet their ongoing fluid requirements during surgery. The ‘Control Group’ will receive no dexamethasone and 100ml of a standard balanced salt solution, with further balanced salt solution to meet their fluid requirements during surgery. We will compare levels of Syndecan-1 (a marker of microvascular function) between the two groups at 5 different time points during and up to 48 hours after the operation to assess if microvascular function differs between the groups. A total of 72 subjects will be included in the study.
Interventions
Dexamethasone sodium phosphate 16mg, intravenous slow push, 30-60 minutes prior to skin incision
AND
20% Albumin 100ml (Albumex 20%) = 20g, intravenous infusion over 30mins, directly following dexamethasone dose
Further intraoperative bolus and maintenance fluid will be delivered as 4% albumin (made with 200ml of 20% albumin (40g) in 1000ml balanced crystalloid solution), titrated by the anaesthetist to meet patient fluid requirements utilising goal directed therapy
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults aged > 18 years • Undergoing elective open bowel resection, pancreatic resection or liver resection surgery • Requiring a hospital stay of at least one postoperative night • Routine use of arterial line for continuous blood pressure monitoring and intermittent positive pressure ventilation via an endotracheal tube as part of standard anaesthesia care • American Society of Anesthesiologists (ASA) Physical status <5
Exclusion criteria
• Poorly controlled diabetes (HbA1c > 9.0% or HbA1c >75 mmol/mol) if known • Allergy to albumin or dexamethasone • Surgery is being performed for treatment of an infective process (e.g. intra-abdominal sepsis) • Planned postoperative intubation or ventilation • Concurrent immunosuppressive therapies or immunosuppressed state • Chronic steroid use (prednisolone 10mg/day or equivalent for greater for >1 week in preceding 3 months) • Pregnant or lactating woman • Surgical procedures within the preceding 2 months or expected within the subsequent 30 days
Outcome results
None listed