Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506372
Status:
TERMINATED
Last Update Posted:
2023-11-29
First Post:
2020-08-06
Brief Title:
Management of Angiotensin Inhibitors During the Perioperative Period
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Angiotensin-converting Enzyme Inhibitors and Angiotensin Receptor Blockers During the Perioperative Period to Withdraw or to Continue A Multicenter Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIPOP
Brief Summary:
This is a multicenter randomized clinical trial to determine the effect of continuation versus withdrawal of angiotensin-converting enzyme inhibitors ACEI and angiotensin receptor blockers ARB in the perioperative period on postoperative complications
Detailed Description:
Rationale
Angiotensin inhibitors including angiotensin convertying enzyme inhibitors ACEI and angiontensin receptors blockers ARB are frequently used to treat patients with chronic hypertension These drugs reduce morbidity and mortality on the long term However when patients who use ACEI or ARB undergo surgery hypotension may occur in the perioperative period which may can lead to organ hypoperfusion and damage On the other hand when ACEI and ARB are temporarily discontinued in the perioperative period hypertension may occur which also may lead to complications Therefore before surgery the anesthesiologist advises the patient to continue or to temporarily withdraw this drug Importantly it is currently unclear which strategy is best and international guidelines are disconcordant on this point Policy varies between hospitals and even between anesthesiologists in some hospitals patients are advised to temporarily withdraw the ACEIARB whilst in other hospitals patients are advised to continue this drug The latest research on this topic suggests that perioperative continuation of ACEIARB may lead to more complications but definitive evidence is lacking Therefore it is important to perform a randomized trial to compare the two options perioperative continuation versus withdrawal of ACEIARB
Objective
The objective of this trial is to determine the effect of continuation versus withdrawal of ACEI and ARB in the perioperative period on postoperative complications expressed as acute kidney injury AKI myocardial injury and quality of life QoL
Study design
This is a multicenter randomized clinical trial
Study population
Patients who use ACEIARB chronically for treatment of hypertension and who are scheduled for an elective intermediate to high risk non-cardiac surgical procedure with an expected postoperative length of hospital stay of at least 2 days are eligible for inclusion Patients who use a combination pill of ACEIARB with a diuretic are eligible as well Patients who use a combination pill ACEIwith another drug will be excluded as well as patients who use other drugs acting on the renin aldosterone angiotensin system
Intervention
The intervention is the withdrawal of ACEIARB in the perioperative period ie 24 hours before surgery until 24-48 hours after surgery The ACEIARB medication is resumed on the second or third day after surgery as soon as the clinical condition allows based on judgement by the attending physician
This intervention will be compared to perioperative continuation of ACEIARB
Main study parametersendpoints
The primary outcome for this study is postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcomes KDIGO guideline
Secondary outcomes include postoperative myocardial injury intraoperative and postoperative hypotension and hypertension length of stay in the hospital or nursing home kidney function loss and end-stage renal disease within three months after surgery major cardiovascular complications myocardial infarction coronary revascularization heart failure arrhythmia stroke within three months after surgery all-cause mortality within three months after surgery and a quality of life QoL assessment
Angiotensin inhibitors including angiotensin convertying enzyme inhibitors ACEI and angiontensin receptors blockers ARB are frequently used to treat patients with chronic hypertension These drugs reduce morbidity and mortality on the long term However when patients who use ACEI or ARB undergo surgery hypotension may occur in the perioperative period which may can lead to organ hypoperfusion and damage On the other hand when ACEI and ARB are temporarily discontinued in the perioperative period hypertension may occur which also may lead to complications Therefore before surgery the anesthesiologist advises the patient to continue or to temporarily withdraw this drug Importantly it is currently unclear which strategy is best and international guidelines are disconcordant on this point Policy varies between hospitals and even between anesthesiologists in some hospitals patients are advised to temporarily withdraw the ACEIARB whilst in other hospitals patients are advised to continue this drug The latest research on this topic suggests that perioperative continuation of ACEIARB may lead to more complications but definitive evidence is lacking Therefore it is important to perform a randomized trial to compare the two options perioperative continuation versus withdrawal of ACEIARB
Objective
The objective of this trial is to determine the effect of continuation versus withdrawal of ACEI and ARB in the perioperative period on postoperative complications expressed as acute kidney injury AKI myocardial injury and quality of life QoL
Study design
This is a multicenter randomized clinical trial
Study population
Patients who use ACEIARB chronically for treatment of hypertension and who are scheduled for an elective intermediate to high risk non-cardiac surgical procedure with an expected postoperative length of hospital stay of at least 2 days are eligible for inclusion Patients who use a combination pill of ACEIARB with a diuretic are eligible as well Patients who use a combination pill ACEIwith another drug will be excluded as well as patients who use other drugs acting on the renin aldosterone angiotensin system
Intervention
The intervention is the withdrawal of ACEIARB in the perioperative period ie 24 hours before surgery until 24-48 hours after surgery The ACEIARB medication is resumed on the second or third day after surgery as soon as the clinical condition allows based on judgement by the attending physician
This intervention will be compared to perioperative continuation of ACEIARB
Main study parametersendpoints
The primary outcome for this study is postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcomes KDIGO guideline
Secondary outcomes include postoperative myocardial injury intraoperative and postoperative hypotension and hypertension length of stay in the hospital or nursing home kidney function loss and end-stage renal disease within three months after surgery major cardiovascular complications myocardial infarction coronary revascularization heart failure arrhythmia stroke within three months after surgery all-cause mortality within three months after surgery and a quality of life QoL assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None