Hypotension on Induction Clinical Trial
Official title:
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 291 |
Est. completion date | December 1, 2016 |
Est. primary completion date | November 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Interoperative Hypotension | Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg) | During anesthesia, an expected average of 3 hours. | |
Secondary | Acute Renal Failure | Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level | Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days. | |
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. | During anesthesia, an expected average of 3 hours. | |
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 | During anesthesia, an expected average of 3 hours. | |
Secondary | Postoperative Hypertension | Any systolic blood pressure greater than 180 mmHg. | Arrival in PACU to hospital discharge, an expected average of 4 days. | |
Secondary | Postoperative Hypotension | Any systolic blood pressure less than 90 mmHg | Arrival in PACU to hospital discharge, an expected average of 4 days. |
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