CompletedPhase 4ACTRN12614001226695

The Perioperative ADministration of Dexamethasone and Infection - The PADDI Trial

The effect in diabetic and non-diabetic surgical patients of the administration of dexamethasone on surgical site infections

Sponsor

Alfred Health, Melbourne

Enrollment

8,880 participants

Start Date

Mar 10, 2016

Study Type

Interventional

Conditions

Perioperative Infective Complications Surgery Diabetes Mellitus

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

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 Criteria18

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

Interested in this trial?

Get notified about updates and connect with the research team.