Trial Outcomes & Findings for Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery (NCT NCT01669434)
NCT ID: NCT01669434
Last Updated: 2023-09-25
Results Overview
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
291 participants
Primary outcome timeframe
During anesthesia, an expected average of 3 hours.
Results posted on
2023-09-25
Participant Flow
Participant milestones
| Measure |
ACEI Omission
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or day before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
145
|
|
Overall Study
COMPLETED
|
137
|
138
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Baseline characteristics by cohort
| Measure |
ACEI Omission
n=137 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=138 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
63.7 years
n=7 Participants
|
63.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
115 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Am Indian/Alaska
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
137 participants
n=5 Participants
|
138 participants
n=7 Participants
|
275 participants
n=5 Participants
|
|
smoking status
Never
|
63 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
smoking status
Former
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
smoking status
Current
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
American Society of Anesthesiologists classification
|
2.8 units on a scale
n=5 Participants
|
2.8 units on a scale
n=7 Participants
|
2.8 units on a scale
n=5 Participants
|
|
preoperative NSAID use
|
53 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
preoperative systolic BP
|
136.6 mmHg
n=5 Participants
|
136.3 mmHg
n=7 Participants
|
136.5 mmHg
n=5 Participants
|
|
hypertension history
|
116 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
congestive heart failure history
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Additional antihypertensive
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During anesthesia, an expected average of 3 hours.Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
Outcome measures
| Measure |
ACEI Omission
n=137 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=138 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Number of Participants With Interoperative Hypotension
|
76 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.Population: Missing outcome data for 37 patients, 18 in the ACEI omission arm and 19 in the ACEI continuation arm
Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level
Outcome measures
| Measure |
ACEI Omission
n=119 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=119 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Acute Renal Failure
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During anesthesia, an expected average of 3 hours.Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.
Outcome measures
| Measure |
ACEI Omission
n=5 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=3 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Low Blood Pressure Subgroup
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During anesthesia, an expected average of 3 hours.Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg
Outcome measures
| Measure |
ACEI Omission
n=70 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=72 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Older Age Subgroup
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Arrival in PACU to hospital discharge, an expected average of 4 days.Any systolic blood pressure greater than 180 mmHg.
Outcome measures
| Measure |
ACEI Omission
n=137 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=138 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Postoperative Hypertension
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Arrival in PACU to hospital discharge, an expected average of 4 days.Any systolic blood pressure less than 90 mmHg
Outcome measures
| Measure |
ACEI Omission
n=137 Participants
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=138 Participants
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Postoperative Hypotension
|
15 Participants
|
31 Participants
|
Adverse Events
ACEI Omission
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
ACEI Continuation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACEI Omission
n=137 participants at risk
Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.
|
ACEI Continuation
n=138 participants at risk
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.
ACEI continuation: These chronic medications will be given without interruption preoperatively.
|
|---|---|---|
|
Cardiac disorders
MACE
|
2.9%
4/137 • Number of events 4 • Hospitalization, expected duration 4 days
|
0.72%
1/138 • Number of events 1 • Hospitalization, expected duration 4 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jason Shiffermiller
University of Nebraska Medical Center
Phone: 402-559-7299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place