A pilot study of preoperative Roxadustat in patients undergoing major surgery.

Phase 2

Recruiting

• Conditions: Surgery - Other surgery; Infection - Other infectious diseases; Postoperative Complications; Surgical site infection

• Registration Number: ACTRN12624000188538
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 18 years or over
2. Undergoing elective major surgery including the following procedures: Oesophagectomy; Gastrectomy; Small bowel resection; Large bowel resection; Hepatectomy; Splenectomy; Pancreatectomy; Nephrectomy; Prostatectomy; Cystectomy; Adrenalectomy; Abdominal aneurysm repair (Open); Femoral-Popliteal Bypass; Total hip replacement; Total knee replacement; Spinal surgery (3 levels or more).

Exclusion Criteria

1. Inability to provide informed consent
2. Peanut or soya allergy
3. Current viral or bacterial infection
4. Pregnancy or breast feeding
5. Epilepsy
6. Severe liver disease (Childs Pugh C)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite of any acute preoperative illness prompting participant to discontinue drug or to seek medical assessment AND/OR any hospital acquired complication (HAC) using the Australian Commission on Safety and Quality in Healthcare definitions.[Preoperative treatment diary, in-hospital bedside assessment, post-discharge phone call and medical record/ ICD-10 coding review. Known adverse reactions listed in the product information leaflet for patients with chronic kidney disease taking long-term (> 6 months) roxadustat include: DVT; PE; vascular access thrombosis; seizures; sepsis; dermatitis; high potassium; high blood pressure; nausea; diarrhoea; peripheral oedema; insomnia; headache; vomiting; constipation; high bilirubin; decreased thyroid function. Day of surgery, day of discharge, postoperative day 30.]

Secondary Outcome Measures

Name	Time	Method
Cellular glycolysis (circulating immune cells)[Gene expression/ RNA analysis Day of surgery (pre-anaesthesia)];Immune function (circulating immune cells)[Flow cytometry Day of surgery (pre-anaesthesia)];Postoperative C-Reactive Protein[Blood tests Postoperative days 1, 2 and 3];Postoperative Troponin[Blood tests Postoperative days 1, 2 and 3];Surgical Site Infection (CDC Criteria)[Phone and medical record assessment Postoperative Day 30];Length of stay[Medical record review Postoperative Day 30];Readmission within 30 days[Medical record review Postoperative Day 30];Days alive and out of hospital in first 30 days[Phone and medical record assessment Postoperative Day 30];Acute kidney injury[Blood tests Postoperative days 1, 2 and 3];Mortality[Medical record review Postoperative Day 30, 1 year after surgery];Enrolment rate equal to or greater than 50 patients/ centre/ year.[Enrolment log Study end];Treatment compliance[Treatment diary Day of surgery]