Management of angiotensin inhibitors during the perioperative period.
- Conditions
- on-cardiac major surgery
- Registration Number
- NL-OMON25483
- Lead Sponsor
- niversity Medical Center Utrecht, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3200
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Chronic ACEI or ARB 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;
-Expected postoperative length of stay of at least two days.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Severe chronic kidney disease, defined as GFR<30 ml/min/1.73 m2;
-ACEI/ARB use for the treatment of chronic systolic heart failure, defined as left ven-tricular ejection fraction =40%;
-ACEI/ARB use within one year after ST-elevated myocardial infarction, according to the fourth universal definition of myocardial infarction;
-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 inhibitors;
-Use of drugs acting on the renin-angiotensin-aldosterone system other than ACEI/ARB, e.g. aliskiren.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome for this study is acute kidney injury, defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guideline as any of the following:<br>-Increase in serum creatinin by =0.3 mg/dl (=26.5 µmol/l) within 48 hours; or<br>-Increase in serum creatinin to =1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or<br>-Urine volume <0.5 ml/kg/h for 6 hours.
- Secondary Outcome Measures
Name Time Method