Angiotensin inhibitors during the perioperative period: to withdraw or to continue?
- Conditions
- 1. Perioperative acute kidney injury2. Perioperative myocardial infarction100285931003843010043413
- Registration Number
- NL-OMON54753
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 334
- Chronic angiotensin-converting enzyme inhibitors and angiotensin receptor
blockers use for the treatment of hypertension. Patients who use a com-bination
pill with a diuretic are eligible as well;
- Scheduled for elective intermediate to high risk noncardiac surgery, defined
according to the European Society of Cardiology / European Society of
Anesthesiology guidelines on noncardiac surgery under general or regional
(spinal, epidural) anesthesia,
- Expected postoperative length of stay of at least one postoperative night
- Severe chronic kidney disease, defined as eGFR<30 ml/min/1.73 m2 -
Angiotensin converting enzyme-inhibitors (ACEi)/Agiotensin receptor blockers
(ARB) use for the treatment of chronic systolic heart failure, defined as left
ventricular ejection fraction <=40%. Patients in whom the ejection fraction
currently has improved to >40% as a result of heart failure treatment (e.g.
ACEi/ARB use or chronic resynchronization therapy (CRT)) are also excluded -
ACEi/ARB use within one year after ST-elevated myocardial infarction, according
to the fourth universal definition of myocardial infarction (20,21) -
Transplant surgery - ACEi/ARB use in a combination pill together with a drug
other than a diuretic, including calcium channel blockers, beta-blockers and
neprilysin inhibitorsUse of drugs acting on the renin-angiotensin-aldosterone
system other than ACEi/ARB, e.g. aliskiren. - Patients who are not able to
manage their medication themselves, e.g. patients who use a medication box or
pill dispenser including the *Baxterrol*. - Urgent (<48 hours of diagnosis) or
emergency surgery - Nephrectomy (partial or complete, no matter the cause) -
Pheochromocytoma surgery - Carotid surgery, including endarterectomy and
carotid bypass surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome for this study is acute kidney injury, defined according to<br /><br>the Kidney Disease Improving Global Outcomes (KDIGO) guideline as any of the<br /><br>following: - Increase in serum creatinin by >=0.3 mg/dl (>=26.5 µmol/l) within 48<br /><br>hours; or - Increase in serum creatinin to >=1.5 times baseline, which is known<br /><br>or presumed to have occurred within the prior 7 days; or - Urine volume <0.5<br /><br>ml/kg/h for 6 hours.</p><br>
- Secondary Outcome Measures
Name Time Method