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

Angiotensin inhibitors during the perioperative period: to withdraw or to continue? - AIPOP (Angiotensin-inhibitors during the perioperative period)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54753
Enrollment
334
Registered
2020-06-24
Start date
2020-09-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Perioperative acute kidney injury 2. Perioperative myocardial infarction

Interventions

Withdrawal of ACEi/ARB in the perioperative period, i.e. from 24 hours before surgery until 24-48 hours after surgery. The ACEi/ARB medication is resumed on the second or third day after surgery as

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Severe chronic kidney disease, defined as eGFR40% 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 (

Design outcomes

Primary

MeasureTime 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

Secondary

MeasureTime frame
- Postoperative myocardial injury, defined as an increased level of serum troponin above the clinical cut-off value; - Intraoperative or postoperative hypotension, defined as a mean arterial pressure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)