None listed
Conditions
Brief summary
The PADDI Trial is a large (8,880 patients) international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, stratified, non-inferiority safety and effectiveness study. It’s purpose is to establish the safety of the administration of 8mg of dexamethasone to adult patients undergoing non-urgent surgical procedures under general anaesthesia of at least two hours duration and requiring at least one night’s stay in hospital postoperatively. Patients will be stratified according to whether or not they are known to have diabetes. The primary outcome is the incidence of surgical site infection at 30 days postoperatively. Secondary outcomes include infection at other sites, and the incidence of chronic post-surgical pain at one year postoperatively. The influence of diabetic status and the quality of control of diabetes on all outcomes will be specifically explored.
Interventions
Dexamethasone 8mg intravenously administered immediately following the induction of anaesthesia
Sponsors
Alfred Health, Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients 18 years or older ASA grade 1-4 (changed to 2-4 in December 2018) Elective or expedited non-cardiac surgery of at least 2 hours duration under general anaesthesia +/- regional block Requiring a hospital stay of at least one postoperative night Surgical skin incision of >5 cm in length or multiple incisions with a total incision length of >5cm
Exclusion criteria
• Poorly controlled diabetes (HbA1c > 9.0%) • Endovascular procedure with a small (< 5 cm length) skin incision • Ophthalmic surgery • Planned dexamethasone (or other corticosteroid) therapy (e.g. history of intractable PONV, maxillofacial surgery, intracranial neurosurgery) • Recent (< 2 weeks since end of treatment) infective episode requiring treatment with antibiotics • Chronic antibiotic therapy (e.g. for bronchiectasis, cystic fibrosis etc) • When surgery is indicated for an infective process (e.g. infected joint prosthesis) • A history of allergy or adverse reaction to glucocorticoids • Planned postoperative intubation or ventilation • Concurrent immunosuppressive therapies • Current or recent (within preceding 1 month) systemic use of glucocorticoids • Surgical procedures within the preceding 2 months • Known immunosuppressed state • Known moderate or severe liver disease (Hepatitis A, B, C, with cirrhotic liver states, primary biliary cirrhosis, sclerosing cholangitis - any of these with portal hypertension and/or variceal bleeding) • Dialysis-dependent renal failure • When the index surgical procedure is expected to require a further surgical procedure within the subsequent 30 days. • Metastatic cancer • Pregnant and lactating women
Outcome results
None listed