<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506372</url>
  </required_header>
  <id_info>
    <org_study_id>AIPOP</org_study_id>
    <nct_id>NCT04506372</nct_id>
  </id_info>
  <brief_title>Management of Angiotensin Inhibitors During the Perioperative Period</brief_title>
  <acronym>AIPOP</acronym>
  <official_title>Angiotensin-converting Enzyme Inhibitors and Angiotensin Receptor Blockers During the Perioperative Period: to Withdraw or to Continue? A Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter randomized clinical trial to determine the effect of continuation&#xD;
      versus withdrawal of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor&#xD;
      blockers (ARB) in the perioperative period on postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Angiotensin inhibitors including angiotensin convertying enzyme inhibitors (ACEI), and&#xD;
      angiontensin receptors blockers (ARB) are frequently used to treat patients with chronic&#xD;
      hypertension. These drugs reduce morbidity and mortality on the long term. However, when&#xD;
      patients who use ACEI or ARB undergo surgery, hypotension may occur in the perioperative&#xD;
      period, which may can lead to organ hypoperfusion and damage. On the other hand, when ACEI&#xD;
      and ARB are temporarily discontinued in the perioperative period, hypertension may occur&#xD;
      which also may lead to complications. Therefore, before surgery the anesthesiologist advises&#xD;
      the patient to continue or to temporarily withdraw this drug. Importantly, it is currently&#xD;
      unclear which strategy is best, and international guidelines are disconcordant on this point.&#xD;
      Policy varies between hospitals and even between anesthesiologists: in some hospitals,&#xD;
      patients are advised to temporarily withdraw the ACEI/ARB, whilst in other hospitals patients&#xD;
      are advised to continue this drug. The latest research on this topic suggests that&#xD;
      perioperative continuation of ACEI/ARB may lead to more complications, but definitive&#xD;
      evidence is lacking. Therefore it is important to perform a randomized trial to compare the&#xD;
      two options: perioperative continuation versus withdrawal of ACEI/ARB.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The objective of this trial is to determine the effect of continuation versus withdrawal of&#xD;
      ACEI and ARB in the perioperative period on postoperative complications, expressed as acute&#xD;
      kidney injury (AKI), myocardial injury, and quality of life (QoL).&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a multicenter randomized clinical trial.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Patients who use ACEI/ARB chronically for treatment of hypertension and who are scheduled for&#xD;
      an elective intermediate to high risk non-cardiac surgical procedure with an expected&#xD;
      postoperative length of hospital stay of at least 2 days, are eligible for inclusion.&#xD;
      Patients who use a combination pill of ACEI/ARB with a diuretic are eligible as well.&#xD;
      Patients who use a combination pill ACEIwith another drug will be excluded, as well as&#xD;
      patients who use other drugs acting on the renin aldosterone angiotensin system.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The intervention is the withdrawal of ACEI/ARB in the perioperative period, i.e. 24 hours&#xD;
      before surgery until 24-48 hours after surgery. The ACEI/ARB medication is resumed on the&#xD;
      second or third day after surgery, as soon as the clinical condition allows based on&#xD;
      judgement by the attending physician.&#xD;
&#xD;
      This intervention will be compared to perioperative continuation of ACEI/ARB.&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
      The primary outcome for this study is postoperative acute kidney injury, defined according to&#xD;
      the Kidney Disease Improving Global Outcomes (KDIGO) guideline.&#xD;
&#xD;
      Secondary outcomes include postoperative myocardial injury, intraoperative and postoperative&#xD;
      hypotension and hypertension, length of stay in the hospital or nursing home, kidney function&#xD;
      loss and end-stage renal disease within three months after surgery, major cardiovascular&#xD;
      complications (myocardial infarction, coronary revascularization, heart failure, arrhythmia,&#xD;
      stroke) within three months after surgery, all-cause mortality within three months after&#xD;
      surgery and a quality of life (QoL) assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    slow recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Actual">February 6, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative acute kidney injury</measure>
    <time_frame>Within two days after surgery</time_frame>
    <description>Postoperative acute kidney injury, defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guideline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative myocardial injury</measure>
    <time_frame>Within two days after surgery</time_frame>
    <description>Postoperative myocardial injury, defined as an increased level of serum troponin above the clinical cut-off value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative myocardial injury</measure>
    <time_frame>Within two days after surgery</time_frame>
    <description>Acute postoperative myocardial injury, defined as an absolute postoperative increase in serum troponin of more than clinical cut-off value as compared to the preoperative value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative hypotension</measure>
    <time_frame>From the start of anesthesia until the end of surgery</time_frame>
    <description>Intraoperative hypotension, defined as a mean arterial pressure &lt;65 mmHg for at least 10 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hypotension</measure>
    <time_frame>From the end of surgery up to and including the second postoperative day</time_frame>
    <description>Postoperative hypotension, defined as a mean arterial pressure &lt;65 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative hypertension</measure>
    <time_frame>Within 24 hours before start of anesthesia</time_frame>
    <description>Preoperative severe hypertension, defined as blood pressure &gt;180/110 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hypertension</measure>
    <time_frame>From the end of surgery up to and including the second postoperative day</time_frame>
    <description>Postoperative severe hypertension, defined as blood pressure &gt;180/110 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Within three months after surgery</time_frame>
    <description>Length of stay in hospital or nursing home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney function loss</measure>
    <time_frame>Within three months after surgery</time_frame>
    <description>Decline in glomerular filtration rate as compared to before surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney function loss</measure>
    <time_frame>Within two days after surgery</time_frame>
    <description>Decline in glomerular filtration rate as compared to before surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-stage renal disease</measure>
    <time_frame>Within three months after surgery</time_frame>
    <description>End-stage renal disease, defined as renal disease requiring dialysis or organ transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major cardiovascular complications</measure>
    <time_frame>Within three months after surgery</time_frame>
    <description>Major cardiovascular complications (myocardial infarction, coronary revascularization, heart failure, arrhythmia, stroke)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within three months after surgery</time_frame>
    <description>All-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>At three months after surgery</time_frame>
    <description>Quality of life based on the EuroQoL 5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>At three months after surgery</time_frame>
    <description>Disability at three months after surgery based on the World Health Organization Disability Activity Score (WHODAS):&#xD;
Change in WHODAS as compared to before surgery (continuous measure);&#xD;
Clinically important change in WHODAS defined as an increase of 5% or more as compared to before surgery;&#xD;
Disability free survival defined as WHODAS &lt;16%;&#xD;
Clinically important disability defined as WHODAS &gt;35%.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Surgery</condition>
  <condition>Angiotensin Hypertension</condition>
  <condition>Perioperative Complication</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perioperative withdrawal of ACEI/ARB.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Perioperative continuation of ACEI/ARB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers</intervention_name>
    <description>Withdrawal 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 soon as the clinical condition allows based on judgement by the attending physician.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Blood will be drawn to measure creatinin and troponin: once before surgery, on the first and second postoperative day, and within 4-8 weeks after surgery</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diary to register drug adherence</intervention_name>
    <description>To register medication adherence, patients will be asked to fill out their medication intake (of ACEI/ARB) in a diary from a week before surgery until surgery.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality of life questionnaire</intervention_name>
    <description>Patients are asked to fill out a quality of life questionnaire (EQ-5D) before surgery and at three months after surgery</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WHODAS questionnaire</intervention_name>
    <description>Patients are asked to fill out a questionnaire about disabilities (WHO Disability Assessment Schedule 2.0) before surgery and at three months after surgery</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic ACEI or ARB use for the treatment of hypertension. Patients who use a&#xD;
             com-bination pill with a diuretic are eligible as well;&#xD;
&#xD;
          -  Scheduled for elective intermediate to high risk noncardiac surgery, defined according&#xD;
             to the European Society of Cardiology / European Society of Anesthesiology guidelines&#xD;
             on noncardiac surgery;&#xD;
&#xD;
          -  Expected postoperative length of stay of at least two days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe chronic kidney disease, defined as GFR&lt;30 ml/min/1.73 m2;&#xD;
&#xD;
          -  ACEI/ARB use for the treatment of chronic systolic heart failure, defined as left&#xD;
             ven-tricular ejection fraction ≤40%;&#xD;
&#xD;
          -  ACEI/ARB use within one year after ST-elevated myocardial infarction, according to the&#xD;
             fourth universal definition of myocardial infarction;&#xD;
&#xD;
          -  Transplant surgery;&#xD;
&#xD;
          -  ACEI/ARB use in a combination pill together with a drug other than a diuretic,&#xD;
             including calcium channel blockers, beta-blockers and neprilysin inhibitors;&#xD;
&#xD;
          -  Use of drugs acting on the renin-angiotensin-aldosterone system other than ACEI/ARB,&#xD;
             e.g. aliskiren.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judith van Waes, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wilton van Klei, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Network Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontorio</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC location AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC location VU</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://www.umcutrecht.nl/en/ziekenhuis/wetenschappelijk-onderzoek/aipop-management-of-angiotensin-inhibitors-during-the-perioperative-period</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Judith van Waes</investigator_full_name>
    <investigator_title>J.A.R. van Waes, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Noncardiac surgery</keyword>
  <keyword>Angiotensin inhibitors</keyword>
  <keyword>Perioperative management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enzyme Inhibitors</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506372
org study id: AIPOP
nct id: NCT04506372
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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 ACEI/ARB, whilst in other hospitals patients
      are advised to continue this drug. The latest research on this topic suggests that
      perioperative continuation of ACEI/ARB 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 ACEI/ARB.

      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 ACEI/ARB 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 ACEI/ARB 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 ACEI/ARB in the perioperative period, i.e. 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 soon as the clinical condition allows based on
      judgement by the attending physician.

      This intervention will be compared to perioperative continuation of ACEI/ARB.

      Main study parameters/endpoints:

      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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Prevention
masking: None (Open Label)
measure: Postoperative acute kidney injury
time frame: Within two days after surgery
description: Postoperative acute kidney injury, defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guideline.
measure: Postoperative myocardial injury
time frame: Within two days after surgery
description: Postoperative myocardial injury, defined as an increased level of serum troponin above the clinical cut-off value
measure: Acute postoperative myocardial injury
time frame: Within two days after surgery
description: Acute postoperative myocardial injury, defined as an absolute postoperative increase in serum troponin of more than clinical cut-off value as compared to the preoperative value
measure: Intraoperative hypotension
time frame: From the start of anesthesia until the end of surgery
description: Intraoperative hypotension, defined as a mean arterial pressure <65 mmHg for at least 10 minutes
measure: Postoperative hypotension
time frame: From the end of surgery up to and including the second postoperative day
description: Postoperative hypotension, defined as a mean arterial pressure <65 mmHg
measure: Preoperative hypertension
time frame: Within 24 hours before start of anesthesia
description: Preoperative severe hypertension, defined as blood pressure >180/110 mmHg
measure: Postoperative hypertension
time frame: From the end of surgery up to and including the second postoperative day
description: Postoperative severe hypertension, defined as blood pressure >180/110 mmHg
measure: Length of stay
time frame: Within three months after surgery
description: Length of stay in hospital or nursing home
measure: Kidney function loss
time frame: Within three months after surgery
description: Decline in glomerular filtration rate as compared to before surgery
measure: Acute kidney function loss
time frame: Within two days after surgery
description: Decline in glomerular filtration rate as compared to before surgery
measure: End-stage renal disease
time frame: Within three months after surgery
description: End-stage renal disease, defined as renal disease requiring dialysis or organ transplantation
measure: Major cardiovascular complications
time frame: Within three months after surgery
description: Major cardiovascular complications (myocardial infarction, coronary revascularization, heart failure, arrhythmia, stroke)
measure: Mortality
time frame: Within three months after surgery
description: All-cause mortality
measure: Quality of life
time frame: At three months after surgery
description: Quality of life based on the EuroQoL 5D questionnaire
measure: Disability
time frame: At three months after surgery
description: Disability at three months after surgery based on the World Health Organization Disability Activity Score (WHODAS):
Change in WHODAS as compared to before surgery (continuous measure);
Clinically important change in WHODAS defined as an increase of 5% or more as compared to before surgery;
Disability free survival defined as WHODAS <16%;
Clinically important disability defined as WHODAS >35%.
arm group label: Intervention group
arm group type: Experimental
description: Perioperative withdrawal of ACEI/ARB.
arm group label: Control group
arm group type: Active Comparator
description: Perioperative continuation of ACEI/ARB.
intervention type: Drug
intervention name: Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers
description: Withdrawal 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 soon as the clinical condition allows based on judgement by the attending physician.
arm group label: Intervention group
intervention type: Diagnostic Test
intervention name: Blood draw
description: Blood will be drawn to measure creatinin and troponin: once before surgery, on the first and second postoperative day, and within 4-8 weeks after surgery
arm group label: Control group
arm group label: Intervention group
intervention type: Behavioral
intervention name: Diary to register drug adherence
description: To register medication adherence, patients will be asked to fill out their medication intake (of ACEI/ARB) in a diary from a week before surgery until surgery.
arm group label: Control group
arm group label: Intervention group
intervention type: Behavioral
intervention name: Quality of life questionnaire
description: Patients are asked to fill out a quality of life questionnaire (EQ-5D) before surgery and at three months after surgery
arm group label: Control group
arm group label: Intervention group
intervention type: Behavioral
intervention name: WHODAS questionnaire
description: Patients are asked to fill out a questionnaire about disabilities (WHO Disability Assessment Schedule 2.0) before surgery and at three months after surgery
arm group label: Control group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith van Waes, MD PhD
role: Principal Investigator
affiliation: UMC Utrecht
last name: Wilton van Klei, MD PhD
role: Principal Investigator
affiliation: UMC Utrecht
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
url: https://www.umcutrecht.nl/en/ziekenhuis/wetenschappelijk-onderzoek/aipop-management-of-angiotensin-inhibitors-during-the-perioperative-period
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Judith van Waes
investigator title: J.A.R. van Waes, MD PhD
mesh term: Hypertension
mesh term: Enzyme Inhibitors
mesh term: Angiotensin-Converting Enzyme Inhibitors