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Angiotensin inhibitors during the perioperative period: to withdraw or to continue?

Completed
Conditions
1. Perioperative acute kidney injury
2. Perioperative myocardial infarction
10028593
10038430
10043413
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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
<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
NameTimeMethod
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