Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 12/13/2017 |
| Start Date: | June 2015 |
| End Date: | December 2016 |
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study
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.
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.
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.
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.
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
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