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

Alfred Health, Melbourne0 个研究点目标入组 8,880 人开始时间: 2014年11月21日最近更新: 2020年8月3日

适应症

试验速览

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•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

•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

发起方

Alfred Health, Melbourne