PROTECT-SPACE II
Many people take medicines called renin-angiotensin system (RAS) inhibitors, such as ACE inhibitors and angiotensin receptor blockers (ARBs), to treat high blood pressure, heart failure or kidney disease. When people taking these medicines need major surgery, doctors must decide whether the medicines should be continued or temporarily stopped around the time of the operation. Currently, there is uncertainty about which approach is best. This project is lead by Dr. Tom Abbott and Professor Rupert Pearse, with funding from the NIHR HTA.
Aim
This study aims to determine whether stopping or continuing RAS inhibitor medicines before major elective non-cardiac surgery leads to better recovery and health outcomes
Open-label randomised platform clinical trial in 2214 patients from 30 NHS hospitals.
Patients aged ≥50 years, awaiting major elective non-cardiac surgery, and taking a RAS-inhibitor (ACE-i and/or ARB with a single active ingredient formulation)
1. Inability or refusal to provide informed consent
2. Clinician refusal to allow a patient to participate
Stopping RAS-inhibitor medicines for a total of seven days during the perioperative period (last dose before surgery to be taken on Day -4 where day of surgery is Day 0, then restarted on Day 4 after surgery)
Continuing RAS-inhibitor medicines during the perioperative period.
Primary outcome measure:
- Days Alive and at Home within 30 days after surgery (DAH30)
Secondary outcome measures:
- Myocardial injury within three days after surgery
- Acute kidney injury within seven days after surgery (KDIGO creatinine criteria)
- High blood pressure events (systolic BP ≥160 mmHg) within seven days after surgery
- Low blood pressure events (systolic BP ≤90 mmHg) within seven days after surgery
- Stroke within 30 days after surgery
- Other post-operative complications within 30 days after surgery (predefined in eCRF)
- Mortality at 180 days after surgery
- Hospital in-patient re-admission within 180 days after surgery
- Health-related quality of life at 30 and 180 days after surgery (EQ-5D-5L)
- Hospital care costs within 180 days after surgery