Non-cardiac major surgery
Conditions
Interventions
The intervention consists of the withdrawal of ACEI/ARB in the perioperative period, i.e. from 24 hours before surgery until 24-48 hours after surgery, in patients who use this medication chronically
Sponsors
University Medical Center Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: -Increase in serum creatinin by =0.3 mg/dl (=26.5 µmol/l) within 48 hours; or -Increase in serum creatinin to =1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or -Urine volume <0.5 ml/kg/h for 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - Postoperative myocardial injury, defined as an increased level of serum troponin above the clinical cut-off value; - Intraoperative hypotension, defined as a mean arterial pressure 180/110 mmHg; - Postoperative severe hypertension, defined as blood pressure >180/110 mmHg from the end of surgery up to and including the second postoperative day; - Length of stay in hospital or nursing home; - End-stage renal disease within three months after surgery, defined as renal disease requiring dialysis or organ transplantation; - Kidney function loss within three months after discharge; - Major cardiovascular complications (myocardial infarction, coronary revascularization, heart failure, arrhythmia, stroke) within three months after surgery; - All-cause mortality within three months after surgery; - Quality of life at three months after surgery based on the EuroQoL 5D questionnaire. | — |
Contacts
Public ContactJudith van Waes
University Medical Center Utrecht
Outcome results
None listed