Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669434

Enrollment

291

Registered

2012-08-21

Start date

2015-06-01

Completion date

2016-12-01

Last updated

2023-09-25

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

Conditions

Hypotension on Induction

Keywords

Perioperative Period

Brief summary

Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Detailed description

The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.

Interventions

DRUGACEI continuation

These chronic medications will be taken without interruption preoperatively.

DRUGACEI omission

Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation. * Above referral must be in anticipation of a non-cardiac, non-vascular surgery. * Must have been on ACE-Inhibitor therapy for at least six weeks.

Exclusion criteria

* Hypotension (systolic blood pressure \< 90 or diastolic blood pressure \<60) at the time of preoperative evaluation * Uncontrolled Hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 95) at the time of preoperative evaluation * Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology) * Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma) * Left Ventricular ejection fraction less than 40% * Clinical evidence of decompensated heart failure at the time of preoperative evaluation * End-stage renal disease * Organ transplant surgeries

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Interoperative Hypotension	During anesthesia, an expected average of 3 hours.	Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)

Secondary

Measure	Time frame	Description
Acute Renal Failure	Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.	Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level
Low Blood Pressure Subgroup	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.
Older Age Subgroup	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
Postoperative Hypertension	Arrival in PACU to hospital discharge, an expected average of 4 days.	Any systolic blood pressure greater than 180 mmHg.
Postoperative Hypotension	Arrival in PACU to hospital discharge, an expected average of 4 days.	Any systolic blood pressure less than 90 mmHg

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 evening before surgery, whenever the last preoperative dose would normally occur.	137
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.	138
Total	275

Baseline characteristics

Characteristic	Total	ACEI Continuation	ACEI Omission
Additional antihypertensive	187 Participants	95 Participants	92 Participants
Age, Continuous	63.9 years	63.7 years	64 years
American Society of Anesthesiologists classification	2.8 units on a scale	2.8 units on a scale	2.8 units on a scale
congestive heart failure history	16 Participants	9 Participants	7 Participants
hypertension history	228 Participants	112 Participants	116 Participants
preoperative NSAID use	124 Participants	71 Participants	53 Participants
preoperative systolic BP	136.5 mmHg	136.3 mmHg	136.6 mmHg
Race/Ethnicity, Customized Am Indian/Alaska	3 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Black	26 Participants	11 Participants	15 Participants
Race/Ethnicity, Customized Caucasian	240 Participants	125 Participants	115 Participants
Race/Ethnicity, Customized Hispanic	2 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Other/Unknown	4 Participants	1 Participants	3 Participants
Region of Enrollment United States	275 participants	138 participants	137 participants
Sex: Female, Male Female	142 Participants	70 Participants	72 Participants
Sex: Female, Male Male	133 Participants	68 Participants	65 Participants
smoking status Current	39 Participants	25 Participants	14 Participants
smoking status Former	119 Participants	59 Participants	60 Participants
smoking status Never	117 Participants	54 Participants	63 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 137	0 / 138
other Total, other adverse events	0 / 137	0 / 138
serious Total, serious adverse events	4 / 137	1 / 138

Outcome results

Primary

Number of Participants With Interoperative Hypotension

Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)

Time frame: During anesthesia, an expected average of 3 hours.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Number of Participants With Interoperative Hypotension	76 Participants
ACEI Continuation	Number of Participants With Interoperative Hypotension	95 Participants

p-value: 0.0395% CI: [0.67, 0.97]Fisher Exact

Secondary

Acute Renal Failure

Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level

Time frame: 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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Acute Renal Failure	6 Participants
ACEI Continuation	Acute Renal Failure	10 Participants

p-value: 0.4495% CI: [0.23, 1.6]Fisher Exact

Secondary

Low Blood Pressure Subgroup

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.

Time frame: During anesthesia, an expected average of 3 hours.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Low Blood Pressure Subgroup	4 Participants
ACEI Continuation	Low Blood Pressure Subgroup	2 Participants

p-value: 195% CI: [0.48, 2.99]Fisher Exact

Secondary

Older Age Subgroup

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

Time frame: During anesthesia, an expected average of 3 hours.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Older Age Subgroup	48 Participants
ACEI Continuation	Older Age Subgroup	49 Participants

p-value: 195% CI: [0.81, 1.26]Fisher Exact

Secondary

Postoperative Hypertension

Any systolic blood pressure greater than 180 mmHg.

Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Postoperative Hypertension	33 Participants
ACEI Continuation	Postoperative Hypertension	17 Participants

p-value: 0.0195% CI: [1.14, 3.34]Fisher Exact

Secondary

Postoperative Hypotension

Any systolic blood pressure less than 90 mmHg

Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
ACEI Omission	Postoperative Hypotension	15 Participants
ACEI Continuation	Postoperative Hypotension	31 Participants

p-value: 0.0295% CI: [0.28, 0.86]Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Interoperative Hypotension

Acute Renal Failure

Low Blood Pressure Subgroup

Older Age Subgroup

Postoperative Hypertension

Postoperative Hypotension